Trials / Completed
CompletedNCT02920229
68Ga-PSMA HBED-PET/CT in the Evaluation of the Biochemical Relapse in Patients With a History of Prostate Cancer Radically Treated
68Ga-PSMA, N,N'-Bis(2-hydroxybenzyl)Ethylenediamine-N,N'-Diacetic Acid (HBED)-PET/CT in the Evaluation of the Biochemical Relapse in Patients With a History of Prostate Cancer Radically Treated
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,230 (actual)
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
- Sex
- Male
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
Single-center, prospective, diagnostic trial in radically treated patients with biochemical recurrence of prostate cancer. Patients with radically treated prostate cancer with biochemical relapse and negativity of all traditional morphological and functional imaging (transrectal ultrasound, bone scan, 18F-FMC PET/CT, CT/MRI) or doubtful imaging of 2-deoxy-2-\[fluorine-18\] (18F)-fluoromethylcholine (FMC) PET/CT will receive a Gallio-68 (68Ga)- Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET)/Computed Tomography (CT) scan.
Detailed description
Single-center, prospective, diagnostic trial. The primary objective of this study is to evaluate the sensitivity of 68Ga-PSMA PET /CT defined as the ratio between the number of 68Ga-PSMA PET /CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging. The secondary objectives are: * Sensitivity for different Prostatic Specific Antigen (PSA) values (ranges) * Sensitivity for different lesion sites * Treatment response assessment with a second PET * False positives detection during Follow Up (FUP) (with other standard methods and eventually optional biopsy) for patient without any treatment * safety 67 evaluable patients will be injected with 100-200 megabecquerel (MBq) 68Ga-PSMA intravenously
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 68Ga- PSMA | 100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2020-10-09
- Completion
- 2020-10-09
- First posted
- 2016-09-30
- Last updated
- 2025-01-09
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02920229. Inclusion in this directory is not an endorsement.