search
Back to results

89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study (89ZR-TLX250)

Primary Purpose

Clear Cell Renal Cell Carcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
89Zr-girentuximab
Sponsored by
Telix International Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Clear Cell Renal Cell Carcinoma focused on measuring clear cell renal cell carcinoma, PET/CT imaging, 89Zr-girentuximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written and voluntarily given Informed Consent
  2. Male or female ≥18 years of age
  3. Imaging evidence of a single indeterminate renal mass of ≤7cm in largest diameter (tumour stage cT1) , on CT or MRI with and without contrast agent, suspicious for ccRCC
  4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
  5. Negative serum pregnancy tests in female patients of childbearing potential (at Screening and within 24 hours prior to receiving investigational product)
  6. for patients included in France only, verification and confirmation of their affiliation with a social security
  7. Sufficient life expectancy to justify nephrectomy
  8. Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration

Exclusion Criteria:

  1. Bioptic procedure (rather than a partial or total nephrectomy) planned for histological species delineation of IRM
  2. Renal mass known to be a metastasis of another primary tumour
  3. Active non-renal malignancy requiring therapy during the time frame of the study participation
  4. Chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
  5. Planned antineoplastic therapies (for the period between administration of 89 Zr-TLX250 and imaging)
  6. Exposure to murine or chimeric antibodies within the last 5 years
  7. Previous administration of any radionuclide within 10 half-lives of the same
  8. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or within the safety of compliance of the subjects as judged by the Investigator
  9. Mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study
  10. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX250
  11. Women who are pregnant or breastfeeding
  12. Known hypersensitivity to Girentuximab or DFO (Desferrioxamine)
  13. Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 millilitres/min/1.73m2
  14. Vulnerable patients (e.g being in detention)

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • University of California, Los Angeles Campus,
  • Emory University
  • Johns Hopkins University Hospital
  • Advanced Molecular Imaging & Therapy, LLC
  • Barbara Ann Karmanos Cancer Hospital
  • Washington University St Louis
  • Memorial Sloan Kettering Cancer Center
  • SEATTLE CANCER CARE ALLIANCE, University of Washington
  • Royal North Shore Hospital
  • Macquarie University Hospital
  • Royal Brisbane and Women's Hospital
  • Princess Alexandra Hospital
  • Austin Health
  • Victorian Comprehensive Cancer Centre
  • Cabrini Hospital
  • Institute Jules Bordet
  • University Hospital Leuven (UZ Leuven)
  • Centre De Recherche Centre hospitalier de l/Universite de Montreal (CrCHUM )
  • Jewish General Hopsital
  • CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec
  • CHU de Bordeaux, Groupe hospitalier Pellegrin
  • CHRU de Nancy, Hopitaux de Brabois
  • Nantes University Hospital Hotel-Dieu
  • Netherlands Cancer Institute
  • Radboud University Medical Centre
  • Ankara University Medical Faculty Hospital
  • Hacettepe University Faculty of Medicine
  • Istanbul Training and Research Hospital
  • Istanbul University Cerrahpasa Medical Faculty
  • Royal Free London NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

89Zr-girentuximab

Arm Description

A single administration of 37 Megabecquerel (MBq) (±10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab, followed by a diagnostic scan on Day 5 ± 2 days after administration.

Outcomes

Primary Outcome Measures

To evaluate sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to noninvasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth.
This outcome will be evaluated on all patients by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This will be compared against the histological determination of the lesion type following resection of the lesion

Secondary Outcome Measures

To determine sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in the subgroup of patients with indeterminate renal masses of ≤ 4 cm in largest diameter (cT1a)
This outcome will be evaluated on all patients with a lesion ≤ 4cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion
To determine specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in the subgroup of patients with indeterminate renal masses of ≤ 4 cm in largest diameter (cT1a)
This outcome will be evaluated on all patients with a lesion ≤ 4cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion
To evaluate positive predictive value (PPV), and accuracy of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses, and in patients with indeterminate renal masses of ≤ 4 cm (cT1a).
This outcome will be determining the proportion (as a percent) of the whole study population in which the PET/CT imaging could correctly predict if an individual patient had clear cell renal cell carcinoma or can correctly predict if the patient did not have clear cell renal cell carcinoma
To define a standardized uptake value (SUV) cut-off for 89Zr-girentuximab, suitable to discriminate ccRCC from non-ccRCC
This outcome will be conducted on the whole study population and will use the counts derived from the PET/CT imaging of the 89Zr in the target tissue in order to see if there is a mathematical way to derive the tumour type information from the imaging alone. The tumour type will be determined by the histological sample obtained following resection.
To evaluate the correlation between 89Zr- girentuximab SUVs and degree of histological carbonic anhydrase IX (CAIX) expression
This outcome will be assessed on all patients. The counts derived from the PET/CT imaging of the renal lesion will be compared with the amount of CAIX expressed in the histologically extracted sample
To evaluate inter-reader variability of diagnostic assessments of 89Zr- girentuximab PET/CT images, when performed by multiple readers
This outcome will be conducted on all patients. Three blinded readers operating independently will be used to read each patient PET/CT image and determine if the target lesion is positive for Zr89. A comparison of findings will then be made between the readers for each patient individually.
To evaluate intra-reader variability of diagnostic assessments of 89Zr- girentuximab PET/CT images
This outcome will be conducted on a randomly determined subset of 10% of the patients. Three readers blinded to the histological outcome will be asked to read each patient PET/CT image on two occasions and determine if the target lesion is positive for Zr89. The results will be evaluated as a percent figure to consistently report the same finding with each patient.
To evaluate safety parameter of Heart rate in patients administered with 89Zr-girentuximab.
This outcome will be measured as beats per minute on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria
To evaluate safety parameter of blood pressure in patients administered with 89Zr-girentuximab.
This outcome will be measured as mmHg on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria
To evaluate negative predictive value (NPV) and accuracy of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses
This outcome will be determining the proportion (as a percent) of the whole study population in which the PET/CT imaging could correctly predict if an individual patient had clear cell renal cell carcinoma or can correctly predict if the patient did not have clear cell renal cell carcinoma
To evaluate safety parameter related to Liver function in patients administered with 89Zr-girentuximab
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
To evaluate safety parameter related to Renal function in patients administered with 89Zr-girentuximab
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
To evaluate safety parameter related to Full Blood Count in patients administered with 89Zr-girentuximab
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
To evaluate sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with IRMs ≤ 3 cm lesions
This outcome will be evaluated on all patients with a lesion ≤ 3 cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
To evaluate sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with IRMs ≤ 2 cm.
This outcome will be evaluated on all patients with a lesion ≤ 2 cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
To evaluate sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with Bosniak 3 lesions.
This outcome will be evaluated on all patients with a Bosniak 3 lesion by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
To evaluate sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with Bosniak 4 lesions.
This outcome will be evaluated on all patients with a Bosniak 4 lesion by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
To evaluate specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with IRMs ≤ 3 cm lesions
This outcome will be evaluated on all patients with a lesion ≤ 3 cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
To evaluate specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with IRMs ≤ 2 cm.
This outcome will be evaluated on all patients with a lesion ≤ 2 cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
To evaluate specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with Bosniak 3 lesions.
This outcome will be evaluated on all patients with a Bosniak 3 by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
To evaluate specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with Bosniak 4 lesions.
This outcome will be evaluated on all patients with a Bosniak 4 by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.

Full Information

First Posted
January 29, 2019
Last Updated
April 12, 2023
Sponsor
Telix International Pty Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT03849118
Brief Title
89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study
Acronym
89ZR-TLX250
Official Title
A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
November 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telix International Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.
Detailed Description
This is a confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed Tomography (PET/CT) imaging to non-invasively detect clear cell renal cell cancer (ccRCC) in adult patients with indeterminate renal masses (IRM), scheduled for partial or total nephrectomy. Patients, will be recruited in 12-15 renal cancer care specialist centres, who have access to state-of-the-art PET/CT imaging equipment. The study involves a single administration of 89Zr-TLX250. Imaging will then be conducted 5 +/-2 days post administration. The partial/total nephrectomy will then be performed at institutional discretion any time following the PET/CT imaging visit, but no later than 90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a central laboratory. On Day 5 +/-2 post study drug administration, an abdominal PET/CT imaging will be obtained. In patients, in which unexpected evidence for disseminated disease is observed, PET/CT imaging may be extended to complete whole body imaging(vertex of skull to toe) at the discretion of the investigator. Image data analyses will be performed by a central image core lab. Qualitative visual analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal lesion, as seen on contrast-enhanced CT or MRI), will be used to assess test performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from the central histological reference laboratory as standard of truth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clear Cell Renal Cell Carcinoma
Keywords
clear cell renal cell carcinoma, PET/CT imaging, 89Zr-girentuximab

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
diagnostic, confirmatory, prospective, multi-centre
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
89Zr-girentuximab
Arm Type
Experimental
Arm Description
A single administration of 37 Megabecquerel (MBq) (±10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab, followed by a diagnostic scan on Day 5 ± 2 days after administration.
Intervention Type
Diagnostic Test
Intervention Name(s)
89Zr-girentuximab
Other Intervention Name(s)
89Zr-TLX250, 89Zr-DFO-TFP-girentuximab (GTX)
Intervention Description
Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days.
Primary Outcome Measure Information:
Title
To evaluate sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to noninvasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth.
Description
This outcome will be evaluated on all patients by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This will be compared against the histological determination of the lesion type following resection of the lesion
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Histological confirmation from nephrectomy material will serve as standard of truth.
Secondary Outcome Measure Information:
Title
To determine sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in the subgroup of patients with indeterminate renal masses of ≤ 4 cm in largest diameter (cT1a)
Description
This outcome will be evaluated on all patients with a lesion ≤ 4cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab.
Title
To determine specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in the subgroup of patients with indeterminate renal masses of ≤ 4 cm in largest diameter (cT1a)
Description
This outcome will be evaluated on all patients with a lesion ≤ 4cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab.
Title
To evaluate positive predictive value (PPV), and accuracy of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses, and in patients with indeterminate renal masses of ≤ 4 cm (cT1a).
Description
This outcome will be determining the proportion (as a percent) of the whole study population in which the PET/CT imaging could correctly predict if an individual patient had clear cell renal cell carcinoma or can correctly predict if the patient did not have clear cell renal cell carcinoma
Time Frame
This analysis will be conducted after all patients have completed study involvement
Title
To define a standardized uptake value (SUV) cut-off for 89Zr-girentuximab, suitable to discriminate ccRCC from non-ccRCC
Description
This outcome will be conducted on the whole study population and will use the counts derived from the PET/CT imaging of the 89Zr in the target tissue in order to see if there is a mathematical way to derive the tumour type information from the imaging alone. The tumour type will be determined by the histological sample obtained following resection.
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab
Title
To evaluate the correlation between 89Zr- girentuximab SUVs and degree of histological carbonic anhydrase IX (CAIX) expression
Description
This outcome will be assessed on all patients. The counts derived from the PET/CT imaging of the renal lesion will be compared with the amount of CAIX expressed in the histologically extracted sample
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab
Title
To evaluate inter-reader variability of diagnostic assessments of 89Zr- girentuximab PET/CT images, when performed by multiple readers
Description
This outcome will be conducted on all patients. Three blinded readers operating independently will be used to read each patient PET/CT image and determine if the target lesion is positive for Zr89. A comparison of findings will then be made between the readers for each patient individually.
Time Frame
This analysis will be conducted through study completion, on average of 5 months
Title
To evaluate intra-reader variability of diagnostic assessments of 89Zr- girentuximab PET/CT images
Description
This outcome will be conducted on a randomly determined subset of 10% of the patients. Three readers blinded to the histological outcome will be asked to read each patient PET/CT image on two occasions and determine if the target lesion is positive for Zr89. The results will be evaluated as a percent figure to consistently report the same finding with each patient.
Time Frame
This analysis will be conducted through study completion, on average of 5 months
Title
To evaluate safety parameter of Heart rate in patients administered with 89Zr-girentuximab.
Description
This outcome will be measured as beats per minute on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria
Time Frame
Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab
Title
To evaluate safety parameter of blood pressure in patients administered with 89Zr-girentuximab.
Description
This outcome will be measured as mmHg on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria
Time Frame
Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab
Title
To evaluate negative predictive value (NPV) and accuracy of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses
Description
This outcome will be determining the proportion (as a percent) of the whole study population in which the PET/CT imaging could correctly predict if an individual patient had clear cell renal cell carcinoma or can correctly predict if the patient did not have clear cell renal cell carcinoma
Time Frame
This analysis will be conducted through study completion, on average 5 months
Title
To evaluate safety parameter related to Liver function in patients administered with 89Zr-girentuximab
Description
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
Time Frame
Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab
Title
To evaluate safety parameter related to Renal function in patients administered with 89Zr-girentuximab
Description
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
Time Frame
Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab
Title
To evaluate safety parameter related to Full Blood Count in patients administered with 89Zr-girentuximab
Description
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
Time Frame
Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab
Title
To evaluate sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with IRMs ≤ 3 cm lesions
Description
This outcome will be evaluated on all patients with a lesion ≤ 3 cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab.
Title
To evaluate sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with IRMs ≤ 2 cm.
Description
This outcome will be evaluated on all patients with a lesion ≤ 2 cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab.
Title
To evaluate sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with Bosniak 3 lesions.
Description
This outcome will be evaluated on all patients with a Bosniak 3 lesion by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab.
Title
To evaluate sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with Bosniak 4 lesions.
Description
This outcome will be evaluated on all patients with a Bosniak 4 lesion by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab.
Title
To evaluate specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with IRMs ≤ 3 cm lesions
Description
This outcome will be evaluated on all patients with a lesion ≤ 3 cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab.
Title
To evaluate specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with IRMs ≤ 2 cm.
Description
This outcome will be evaluated on all patients with a lesion ≤ 2 cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab.
Title
To evaluate specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with Bosniak 3 lesions.
Description
This outcome will be evaluated on all patients with a Bosniak 3 by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab.
Title
To evaluate specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with Bosniak 4 lesions.
Description
This outcome will be evaluated on all patients with a Bosniak 4 by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab.
Other Pre-specified Outcome Measures:
Title
To quantitatively estimate achievable radiation absorbed doses (Gy) for therapeutic 177 Lutetium-girentuximab based on single time point 89Zr-girentuximab PET/CT images.
Description
This outcome will be assessed by determining the radiation absorbed dose, using Monte Carlo analysis, that would have been delivered to the target tissue had the girentuximab been bound alternatively with the therapeutic radionuclide 177Lu, rather than the diagnostic 89Zr label.
Time Frame
This analysis will be conducted after all patients have completed study involvement, an average of 1 year
Title
To quantitatively estimate achievable tumour uptake, retention and radiation absorbed doses (Gy) for therapeutic 177Lu-girentuximab, based on a general model of average girentuximab tumour kinetics derived from serial 89Zr-girentuximab imaging.
Description
This outcome will be assessed by determining the radiation absorbed dose, using Monte Carlo analysis, that would have been delivered to the target tissue had the girentuximab been bound alternatively with the therapeutic radionuclide 177Lu, rather than the diagnostic 89Zr label.
Time Frame
This analysis will be conducted after all patients have completed study involvement, an average of 1 year
Title
To quantitatively estimate achievable tumour uptake, retention and radiation absorbed doses (Gy) for therapeutic 177Lu-girentuximab, based on an assumed specific activity of 177Lu-girentuximab.
Description
This outcome will be assessed by determining the radiation absorbed dose, using Monte Carlo analysis, that would have been delivered to the target tissue had the girentuximab been bound alternatively with the therapeutic radionuclide 177Lu, rather than the diagnostic 89Zr label.
Time Frame
This analysis will be conducted after all patients have completed study involvement, an average of 1 year
Title
To evaluate the correlation between 89Zr-TLX250 SUVs and degree of histological CAIX expression.
Description
This outcome will be conducted on the whole study population and will use the counts derived from the PET/CT imaging of the 89Zr in the target tissue and compare it to the CAIX expression determined by the histological sample obtained following resection.
Time Frame
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab
Title
To evaluate distant masses outside the kidney identified on 89Zr-TLX250 whole body PET/CT in patients who present with unexpected evidence of disseminated disease.
Description
This outcome will be conducted on all patients. Three blinded readers operating independently will be used to read each patient PET/CT image and determine if there is evidence of disseminated disease with Zr89 which was not previously known.
Time Frame
This analysis will be conducted after all patients have completed study involvement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written and voluntarily given Informed Consent Male or female ≥18 years of age Imaging evidence of a single indeterminate renal mass of ≤7cm in largest diameter (tumour stage cT1) , on CT or MRI with and without contrast agent, suspicious for ccRCC Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration Negative serum pregnancy tests in female patients of childbearing potential (at Screening and within 24 hours prior to receiving investigational product) for patients included in France only, verification and confirmation of their affiliation with a social security Sufficient life expectancy to justify nephrectomy Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration Exclusion Criteria: Bioptic procedure (rather than a partial or total nephrectomy) planned for histological species delineation of IRM Renal mass known to be a metastasis of another primary tumour Active non-renal malignancy requiring therapy during the time frame of the study participation Chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) Planned antineoplastic therapies (for the period between administration of 89 Zr-TLX250 and imaging) Exposure to murine or chimeric antibodies within the last 5 years Previous administration of any radionuclide within 10 half-lives of the same Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or within the safety of compliance of the subjects as judged by the Investigator Mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX250 Women who are pregnant or breastfeeding Known hypersensitivity to Girentuximab or DFO (Desferrioxamine) Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 millilitres/min/1.73m2 Vulnerable patients (e.g being in detention)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Gurney, MD
Organizational Affiliation
Macquarie University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francoise Brodere, MD
Organizational Affiliation
University Hospital ICO, Nantes, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Mulders, MD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcel Stokkel, MD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Declan Murphy, MD
Organizational Affiliation
Victorian Comprehensive Cancer Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Scott, MD
Organizational Affiliation
Olivia Newton John Cancer Research Center, Austin Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simon Wood, MD
Organizational Affiliation
Princess Alexander Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Frydenberg, MD
Organizational Affiliation
Cabrini Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Chan
Organizational Affiliation
Royal North Shore Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Bernhard, MD
Organizational Affiliation
CHU de Bordeaux, Groupe Hospitalier Pellegrin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Olivier, MD
Organizational Affiliation
CHRU de Nancy - Hôpitaux de Brabois
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda Heijmen, MD
Organizational Affiliation
Leiden University Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Geert Steffens, MD
Organizational Affiliation
Isala
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karolien Goffin, MD
Organizational Affiliation
Universitair Ziekenhuis Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Artigas Guix, MD
Organizational Affiliation
Instutit Jules Bordet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicolas Lumen, MD
Organizational Affiliation
Universitair Ziekenhuis Gent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sumer Baltaci, MD
Organizational Affiliation
Ankara University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bulent Akdogan, MD
Organizational Affiliation
Ankara Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bulent Onal, MD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tamer Aksoy, MD
Organizational Affiliation
Istanbul Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California, Los Angeles Campus,
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Johns Hopkins University Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Advanced Molecular Imaging & Therapy, LLC
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
SEATTLE CANCER CARE ALLIANCE, University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Macquarie University Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Victorian Comprehensive Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Cabrini Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Institute Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
University Hospital Leuven (UZ Leuven)
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre De Recherche Centre hospitalier de l/Universite de Montreal (CrCHUM )
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X0C1
Country
Canada
Facility Name
Jewish General Hopsital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec
City
Québec
ZIP/Postal Code
G1R2J6
Country
Canada
Facility Name
CHU de Bordeaux, Groupe hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHRU de Nancy, Hopitaux de Brabois
City
Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Nantes University Hospital Hotel-Dieu
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Radboud University Medical Centre
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Ankara University Medical Faculty Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe University Faculty of Medicine
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Istanbul Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study

We'll reach out to this number within 24 hrs