Back to results

A Single-centre, Open-label, Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP Study) (ZiPUP)

Primary Purpose

Urothelial Carcinoma

Status

Unknown status

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

89Zr-Girentuximab

About this trial

This is an interventional diagnostic trial for Urothelial Carcinoma focused on measuring Glandular and Epithelial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients aged 18 or older with bladder cancer or urothelial carcinoma who are able to provide informed consent
Negative serum pregnancy test in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
Consent to practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration.

Exclusion Criteria:

Active malignancy other than urothelial carcinoma or bladder cancer
Administration of a radioisotope within 10 physical half-lives prior to study enrolment.
Administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89Zr-TLX250 or continuing adverse effects from such therapy
Planned antineoplastic therapies for the period between administration of 89Zr-TLX250 and imaging
Serious non-malignant disease that may interfere with the objectives of the study
Renal insufficiency with glomerular filtration rate ≤45 mL/min/1.73m2
Pregnancy or lactation
Exposure to murine or chimeric antibodies within the last 5 years
Known hypersensitivity or human anti-chimeric antibodies against girentuximab
Exposure to any experimental diagnostic or therapeutic drug 30 days prior to the date of planned administration of 89Zr-TLX250
Contraindications to FDG PET/CT

Sites / Locations

Fiona Stanley HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Staging cohort

Metastatic cohort

Arm Description

Eligible participants recruited to the staging cohort

Eligible participants recruited from the metastatic cohort

Outcomes

Primary Outcome Measures

Comparison of the sensitivity and specificity of 89Zr-girentuximab PET with FDG PET

Sensitivity and specificity will be established following histological confirmation

Secondary Outcome Measures

To evaluate the correlation between 89Zr-girentuximab SUV's and degree of urinary carbonic anhydrase IX excretion (cytology and CA-IX via PCR).

89Zr-girentuximab SUV's will be correlated with urinary CA-IX expression

To evaluate safety parameters related to 89Zr-girentuximab administration

Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v 5.0 criteria

To evaluate the correlation between tumour volume using MIM quantitative software and histopathological findings

Tumour burden as defined by volumetric software will be correlated with histopathological results

Full Information

NCT ID

NCT05046665

First Posted

September 8, 2021

Last Updated

September 8, 2021

Sponsor

South Metropolitan Health Service

Collaborators

Telix International Pty Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05046665

Brief Title

A Single-centre, Open-label, Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP Study)

Acronym

ZiPUP

Official Title

A Single-centre, Open-label, Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP Study)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 14, 2021 (Actual)

Primary Completion Date

March 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

South Metropolitan Health Service

Collaborators

Telix International Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of this study is to determine if it is practical to use 89Zr-TLX250 PET/CT in the staging and detection of localized and metastatic urothelial carcinoma or bladder cancer. The primary objective is to evaluate the feasibility of using 89Zr-TLX250 PET/CTas a new diagnostic and staging modality to detect urothelial carcinoma or bladder cancer.

Detailed Description

This will be a non-randomised, non-blinded, single centre, phase 1 feasibility study comparing 89Zr-girentuximab PET with FDG PET in patients with urothelial carcinoma or bladder cancer. This study would include 2 cohorts of adult patients; those with known metastatic urothelial carcinoma and bladder cancer and those undergoing primary staging for recently diagnosed urothelial carcinoma or bladder cancer. This study is open-label, single centre and eligible patients will receive a single administration of study drug prior to imaging on day 5 (+/- 2 days). PET scans will be independently interpreted by nuclear medicine physicians blinded to the FDG PET findings. For patients proceeding to radical cystectomy, subsequent histological confirmation of areas of increased uptake will be retrospectively correlated with both PET scans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urothelial Carcinoma

Keywords

Glandular and Epithelial

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Staging cohort

Arm Type

Other

Arm Description

Eligible participants recruited to the staging cohort

Arm Title

Metastatic cohort

Arm Type

Other

Arm Description

Eligible participants recruited from the metastatic cohort

Intervention Type

Drug

Intervention Name(s)

89Zr-Girentuximab

Intervention Description

Administration of 89Zr-girentuximab as per protocol.

Primary Outcome Measure Information:

Title

Comparison of the sensitivity and specificity of 89Zr-girentuximab PET with FDG PET

Description

Sensitivity and specificity will be established following histological confirmation

Time Frame

Day 1 - Day 90

Secondary Outcome Measure Information:

Title

To evaluate the correlation between 89Zr-girentuximab SUV's and degree of urinary carbonic anhydrase IX excretion (cytology and CA-IX via PCR).

Description

89Zr-girentuximab SUV's will be correlated with urinary CA-IX expression

Time Frame

Day 1

Title

To evaluate safety parameters related to 89Zr-girentuximab administration

Description

Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v 5.0 criteria

Time Frame

Day 1 to Day 90

Title

To evaluate the correlation between tumour volume using MIM quantitative software and histopathological findings

Description

Tumour burden as defined by volumetric software will be correlated with histopathological results

Time Frame

Day 1 - Day 90

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged 18 or older with bladder cancer or urothelial carcinoma who are able to provide informed consent Negative serum pregnancy test in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product. Consent to practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration. Exclusion Criteria: Active malignancy other than urothelial carcinoma or bladder cancer Administration of a radioisotope within 10 physical half-lives prior to study enrolment. Administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89Zr-TLX250 or continuing adverse effects from such therapy Planned antineoplastic therapies for the period between administration of 89Zr-TLX250 and imaging Serious non-malignant disease that may interfere with the objectives of the study Renal insufficiency with glomerular filtration rate ≤45 mL/min/1.73m2 Pregnancy or lactation Exposure to murine or chimeric antibodies within the last 5 years Known hypersensitivity or human anti-chimeric antibodies against girentuximab Exposure to any experimental diagnostic or therapeutic drug 30 days prior to the date of planned administration of 89Zr-TLX250 Contraindications to FDG PET/CT

Facility Information:

Facility Name

Fiona Stanley Hospital

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dickon Hayne

Phone

61 8 6152 2222

dickon.hayne@uwa.edu.au

First Name & Middle Initial & Last Name & Degree

Cynthia Hawks

Phone

61 8 6152 6916

Cynthia.Hawks@health.wa.gov.au

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35428649

Citation

Al-Zubaidi M, Viswambaram P, McCombie S, Liow E, Lenzo N, Ferguson T, Redfern AD, Gauci R, Hayne D. 89Zirconium-labelled girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP): protocol for a phase I trial of a novel staging modality for urothelial carcinoma. BMJ Open. 2022 Apr 15;12(4):e060478. doi: 10.1136/bmjopen-2021-060478.

Results Reference

derived

Learn more about this trial

A Single-centre, Open-label, Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP Study)

We'll reach out to this number within 24 hrs