Trials / Completed
CompletedNCT03001869
68Ga-PSMA PET/CT in Prostate Cancer
The Safety and Efficacy of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 540 (actual)
- Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital · Academic / Other
- Sex
- Male
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and as a diagnostic and decision making tool in the management prostate cancer patients.The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a per-patient and per-lesion basis.
Detailed description
Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine diagnostic imaging procedure based on the measurement of positron emission from radiolabeled tracer molecules in vivo. A radiotracer in use today is 68Ga-HBED-CC-PSMA (DKFZ-11) - hereinafter abbreviated 68Ga-PSMA - which is a radiolabeled urea-based ligand for prostate specific membrane antigen (PSMA) PET/CT. Imaging with 68Ga-PSMA PET is used to characterize and localize prostate cancer in humans in vivo. There is extensive data in the literature showing the value of 68Ga-PSMA PET/CT imaging in accurately staging and restaging prostate cancer. The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and to establish our ability to reproduce results from the literature using 68Ga-PSMA PET/CT as a diagnostic and decision making tool in the management prostate cancer patients. During the study eligible prostate cancer patients will undergo one 68Ga-PSMA PET/CT. The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a per-patient and per-lesion basis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 68Ga-HBED-CC-PSMA PET/CT | 68Ga-HBED-CC-PSMA PET/CT Scan |
Timeline
- Start date
- 2017-07-01
- Primary completion
- 2023-07-01
- Completion
- 2023-07-01
- First posted
- 2016-12-23
- Last updated
- 2023-11-27
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT03001869. Inclusion in this directory is not an endorsement.