Back to resultsStudy of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection (GuideView)
Primary Purpose
Prostatic Neoplasms, Prostate Cancer
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
[18F]CTT1057
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostatic Neoplasms focused on measuring [18F]CTT1057, Positron Emission Tomography/Computerized Tomography, PET/CT, Radioligand, Imaging, Primary Staging, PS, Standard of Truth, SoT, Prostate Cancer, PCa
Eligibility Criteria
Inclusion Criteria:
- Untreated high risk biopsy-proven PCa patients according to D'Amico classification (Stage ≥ T2c or PSA level >20ng/ml or Gleason score ≥8) (D'Amico et al 1998)
- Scheduled or planned radical prostatectomy and extended pelvic lymph node resection up to 6 weeks after the investigational PET/CT scan followed by histopathology assessment
- ECOG performance status 0-2
- Signed informed consent must be obtained prior to participation in the study
- Participants must be adults ≥ 18 years of age
Exclusion Criteria:
- Inability to complete the needed investigational and standard-of-care imaging examinations due to any reason (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
- Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation, including, but not limited to, current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, need of indwelling/condom catheters, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, and COVID-19.
- Known allergy, hypersensitivity, or intolerance to [18F]CTT1057
- Prior and current use of PSMA targeted therapies
- Prior and current treatment with any ADT (first or second generation), including LHRH analogues (agonists or antagonists)
- Any 5-alpha reductase inhibitors within 30 days before screening
- Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
- Patients with incidental PCa after transurethral resection
- Use of other investigational drugs within 30 days before screening
Sites / Locations
- Explorer Molecular Imaging center
- Novartis Investigative SiteRecruiting
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative SiteRecruiting
- Novartis Investigative Site
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET/CT imaging with [18F]CTT1057
Arm Description
All eligible participants will be enrolled to receive [18F]CTT1057 imaging agent on Day 1 and have PET/CT scan
Outcomes
Primary Outcome Measures
Patient-level sensitivity of [18F]CTT1057
Sensitivity of [18F]CTT1057 PET imaging, considering PSMA positive patients as those who show at least one pathological [18F]CTT1057 uptake either in the primary tumor and/or metastatic PLN regions, with anatomically localized correspondence with the SoT.
Region-level specificity of [18F]CTT1057
Specificity of [18F]CTT1057 PET imaging, defined as proportion of PLN regions that test negative for lymph nodes on [18F]CTT1057 among those that are lymph node negative on the SoT.
Secondary Outcome Measures
Patient-level specificity of [18F]CTT1057
Specificity of [18F]CTT1057 PET imaging, considering PSMA negative patients as those who do not show any pathological [18F]CTT1057 uptake either in the primary tumor or PLNs and will be confirmed not having primary tumor or metastatic PLNs with the SoT
Patient-level positive predictive value of [18F]CTT1057
Proportion of patients who are both [18F]CTT1057 and SoT positive (true positives (TP) among those who test positive on [18F]CTT1057 (TP+ false positives(FP)
Patient-level negative predictive value of [18F]CTT1057
Proportion of patients who are both [18F]CTT1057 and SoT negative (true negatives (TN)) among those who test negative on [18F]CTT1057 (TN+ false negatives (FN))
Patient-level accuracy of [18F]CTT1057
Proportion of patients that are SoT and [18F]CTT1057 positive (TP) and negative (TN) among all patients in EFF (TP+TN+FP+FN)
Region-level sensitivity of [18F]CTT1057 for patients excluding micro-metastasis
Sensitivity of [18F]CTT1057 PET imaging in the PLN region, excluding from the analysis those lymph nodes showing metastasis <2mm (micro-metastasis)
Region-level sensitivity of [18F]CTT1057
Proportion of PLN regions that test positive on both [18F]CTT1057 and SoT (TP) among those that are SoT positive (TP+FN)
Region-level positive predictive value of [18F]CTT1057
Proportion of PLN regions that are SoT and [18F]CTT1057 positive (TP) among those regions that test positive on [18F]CTT1057 (TP+FP)
Region-level negative predictive value of [18F]CTT1057
Proportion of PLN regions that are SoT and [18F]CTT1057 negative (TN) among those regions that test negative on [18F]CTT1057 (TN+FN)
Region-level accuracy of [18F]CTT1057
Proportion of PLN regions that are SoT and [18F]CTT1057 positive (TP) and negative (TN) among all PLN regions assessed [18F]CTT1057 (TP+TN+FP+FN)
Detection of distant metastasis in PS patients
Number of distant metastasis identified at PET/CT scan in all patients, and percentage of patients with at least one distant metastatic lesion (extra-PLN, visceral or skeletal)identified by PET scan in all patients with an evaluable [18F]CTT1057 PET/CT scan.
Characterize the safety and tolerability of [18F]CTT1057
The distribution of adverse events (AEs) within 14 days after the administration of [18F]CTT1057 will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
[18F]CTT1057 scan inter-reader variability
Scan inter-reader variability is defined the agreement rate among reader determination of [18F]CTT1057 images.
[18F]CTT1057 scan intra-reader variability
Scan intra-reader variability is defined as the within-reader agreement rate of [18F]CTT1057 images.
Observed maximum blood concentration (Cmax) of [18F]CTT1057
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. Cmax will be listed and summarized using descriptive statistics.
Time of maximum observed blood concentration occurrence (Tmax) of [18F]CTT1057
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. Tmax will be listed and summarized using descriptive statistics.
Area under the [18F]CTT1057 concentration-time curve from time zero to the time of last quantifiable concentration (AUClast)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. AUClast will be listed and summarized using descriptive statistics.
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of [18F]CTT1057
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. AUCinf will be listed and summarized using descriptive statistics.
Terminal elimination half-life (T1/2) of [18F]CTT1057
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. The half-life will be listed and summarized using descriptive statistics.
Volume of distribution during the terminal phase following intravenous elimination (Vz) of [18F]CTT1057
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. Vz will be listed and summarized using descriptive statistics.
Total systemic clearance for intravenous administration (CL) of [18F]CTT1057
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. CL will be listed and summarized using descriptive statistics.
Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA) of [18F]CTT1057
Urine samples will be collected over specified time intervals and analyzed for radioactivity in a subset of approximately 10 patients. The radioactivity excreted in each interval as a percentage of injected activity (%IA) will be listed and summarized using descriptive statistics.
Full Information
NCT ID
NCT04838626
First Posted
April 7, 2021
Last Updated
October 17, 2023
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT04838626
Brief Title
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
Acronym
GuideView
Official Title
Phase II/III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging for the Detection of PSMA Positive Tumors Using Histopathology as a Standard of Truth
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
November 16, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk prostate cancer (PCa) will be used for the histopathology assessments.
Approximately 195 participants will be enrolled to ensure that at least 156 participants are evaluable (i.e. have both an evaluable PET/CT scan and histopathology assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery), which will be required for the calculation of the co-primary endpoints.
Detailed Description
This is a multi-center, single-arm, open-label prospective study to evaluate the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors, using histopathology as SoT. Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk PCa will be used for the histopathology assessments.
All participants will receive [18F]CTT1057 for PET/CT scan imaging, and surgery (radical prostatectomy and extended pelvic lymph node dissection) will be performed up to 6 weeks after but not sooner than 48 hours after the completion of the [18F]CTT1057 PET/CT scan for pathology assessment of the tissue specimens.
The co-primary endpoints of patient-level sensitivity and region-level specificity will be assessed by comparing the central reading results of the [18F]CTT1057 PET scan to the histopathology results in the dissected tissue specimens, i.e. both the primary tumor and the dissected Pelvic Lymph Node (PLN)).
Pathology will be assessed by the local pathologists as per Standard of Care (SoC), who will be blinded to the PET data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Prostate Cancer
Keywords
[18F]CTT1057, Positron Emission Tomography/Computerized Tomography, PET/CT, Radioligand, Imaging, Primary Staging, PS, Standard of Truth, SoT, Prostate Cancer, PCa
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive [18F]CTT1057 for PET/CT scan imaging, and surgery will be performed up to 6 weeks after [18F]CTT1057 PET for pathology assessment of the tissue specimens.
Additional pharmacokinetics (PK) assessments will be performed on the date of imaging in a subset of approximately 10 patients at the same site.
Masking
None (Open Label)
Allocation
N/A
Enrollment
195 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PET/CT imaging with [18F]CTT1057
Arm Type
Experimental
Arm Description
All eligible participants will be enrolled to receive [18F]CTT1057 imaging agent on Day 1 and have PET/CT scan
Intervention Type
Drug
Intervention Name(s)
[18F]CTT1057
Other Intervention Name(s)
Single intravenous dose of approximately 370 Mega-Becquerel (MBq) and subsequent PET/CT scan
Intervention Description
PET/CT imaging with [18F]CTT1057
Primary Outcome Measure Information:
Title
Patient-level sensitivity of [18F]CTT1057
Description
Sensitivity of [18F]CTT1057 PET imaging, considering PSMA positive patients as those who show at least one pathological [18F]CTT1057 uptake either in the primary tumor and/or metastatic PLN regions, with anatomically localized correspondence with the SoT.
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Title
Region-level specificity of [18F]CTT1057
Description
Specificity of [18F]CTT1057 PET imaging, defined as proportion of PLN regions that test negative for lymph nodes on [18F]CTT1057 among those that are lymph node negative on the SoT.
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Secondary Outcome Measure Information:
Title
Patient-level specificity of [18F]CTT1057
Description
Specificity of [18F]CTT1057 PET imaging, considering PSMA negative patients as those who do not show any pathological [18F]CTT1057 uptake either in the primary tumor or PLNs and will be confirmed not having primary tumor or metastatic PLNs with the SoT
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Title
Patient-level positive predictive value of [18F]CTT1057
Description
Proportion of patients who are both [18F]CTT1057 and SoT positive (true positives (TP) among those who test positive on [18F]CTT1057 (TP+ false positives(FP)
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Title
Patient-level negative predictive value of [18F]CTT1057
Description
Proportion of patients who are both [18F]CTT1057 and SoT negative (true negatives (TN)) among those who test negative on [18F]CTT1057 (TN+ false negatives (FN))
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Title
Patient-level accuracy of [18F]CTT1057
Description
Proportion of patients that are SoT and [18F]CTT1057 positive (TP) and negative (TN) among all patients in EFF (TP+TN+FP+FN)
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Title
Region-level sensitivity of [18F]CTT1057 for patients excluding micro-metastasis
Description
Sensitivity of [18F]CTT1057 PET imaging in the PLN region, excluding from the analysis those lymph nodes showing metastasis <2mm (micro-metastasis)
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Title
Region-level sensitivity of [18F]CTT1057
Description
Proportion of PLN regions that test positive on both [18F]CTT1057 and SoT (TP) among those that are SoT positive (TP+FN)
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Title
Region-level positive predictive value of [18F]CTT1057
Description
Proportion of PLN regions that are SoT and [18F]CTT1057 positive (TP) among those regions that test positive on [18F]CTT1057 (TP+FP)
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Title
Region-level negative predictive value of [18F]CTT1057
Description
Proportion of PLN regions that are SoT and [18F]CTT1057 negative (TN) among those regions that test negative on [18F]CTT1057 (TN+FN)
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Title
Region-level accuracy of [18F]CTT1057
Description
Proportion of PLN regions that are SoT and [18F]CTT1057 positive (TP) and negative (TN) among all PLN regions assessed [18F]CTT1057 (TP+TN+FP+FN)
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Title
Detection of distant metastasis in PS patients
Description
Number of distant metastasis identified at PET/CT scan in all patients, and percentage of patients with at least one distant metastatic lesion (extra-PLN, visceral or skeletal)identified by PET scan in all patients with an evaluable [18F]CTT1057 PET/CT scan.
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Title
Characterize the safety and tolerability of [18F]CTT1057
Description
The distribution of adverse events (AEs) within 14 days after the administration of [18F]CTT1057 will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Time Frame
From first dosing (Day 1) up to 14 days post dosing
Title
[18F]CTT1057 scan inter-reader variability
Description
Scan inter-reader variability is defined the agreement rate among reader determination of [18F]CTT1057 images.
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Title
[18F]CTT1057 scan intra-reader variability
Description
Scan intra-reader variability is defined as the within-reader agreement rate of [18F]CTT1057 images.
Time Frame
[18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan
Title
Observed maximum blood concentration (Cmax) of [18F]CTT1057
Description
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. Cmax will be listed and summarized using descriptive statistics.
Time Frame
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
Title
Time of maximum observed blood concentration occurrence (Tmax) of [18F]CTT1057
Description
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. Tmax will be listed and summarized using descriptive statistics.
Time Frame
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
Title
Area under the [18F]CTT1057 concentration-time curve from time zero to the time of last quantifiable concentration (AUClast)
Description
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. AUClast will be listed and summarized using descriptive statistics.
Time Frame
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
Title
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of [18F]CTT1057
Description
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. AUCinf will be listed and summarized using descriptive statistics.
Time Frame
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post infusion)
Title
Terminal elimination half-life (T1/2) of [18F]CTT1057
Description
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. The half-life will be listed and summarized using descriptive statistics.
Time Frame
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
Title
Volume of distribution during the terminal phase following intravenous elimination (Vz) of [18F]CTT1057
Description
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. Vz will be listed and summarized using descriptive statistics.
Time Frame
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
Title
Total systemic clearance for intravenous administration (CL) of [18F]CTT1057
Description
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of approximately 10 patients. CL will be listed and summarized using descriptive statistics.
Time Frame
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
Title
Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA) of [18F]CTT1057
Description
Urine samples will be collected over specified time intervals and analyzed for radioactivity in a subset of approximately 10 patients. The radioactivity excreted in each interval as a percentage of injected activity (%IA) will be listed and summarized using descriptive statistics.
Time Frame
Day 1 (pre-injection/0 hour, 0 hour (injection) - T (image acquisition starting time), T (image acquisition starting time) to 3 hours, 3 hours to 5 hours post imaging)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Untreated high risk biopsy-proven PCa patients according to D'Amico classification (Stage ≥ T2c or PSA level >20ng/ml or Gleason score ≥8) (D'Amico et al 1998)
Scheduled or planned radical prostatectomy and extended pelvic lymph node resection up to 6 weeks after the investigational PET/CT scan followed by histopathology assessment
ECOG performance status 0-2
Signed informed consent must be obtained prior to participation in the study
Participants must be adults ≥ 18 years of age
Exclusion Criteria:
Inability to complete the needed investigational and standard-of-care imaging examinations due to any reason (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation, including, but not limited to, current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, need of indwelling/condom catheters, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, and COVID-19.
Known allergy, hypersensitivity, or intolerance to [18F]CTT1057
Prior and current use of PSMA targeted therapies
Prior and current treatment with any ADT (first or second generation), including LHRH analogues (agonists or antagonists)
Any 5-alpha reductase inhibitors within 30 days before screening
Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
Patients with incidental PCa after transurethral resection
Use of other investigational drugs within 30 days before screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Email
novartis.email@novartis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Explorer Molecular Imaging center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nimes Cedex 9
ZIP/Postal Code
30029
Country
France
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Toulouse 4
ZIP/Postal Code
31054
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Bergamo
State/Province
BG
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20019
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Geneve
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Completed
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Learn more about this trial
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
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