Trials / Completed
CompletedNCT03739684
Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 208 (actual)
- Sponsor
- Progenics Pharmaceuticals, Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 18F-DCFPyL | A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL |
| DIAGNOSTIC_TEST | PET/CT Imaging | PET/CT imaging will be acquired 1-2 hours post-PyL injection |
Timeline
- Start date
- 2018-11-27
- Primary completion
- 2019-08-29
- Completion
- 2019-08-29
- First posted
- 2018-11-14
- Last updated
- 2021-06-14
- Results posted
- 2021-06-14
Locations
14 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03739684. Inclusion in this directory is not an endorsement.