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NCT02680041 · ClinicalTrials.gov registry record · Phase 3
18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment
A Phase 3 study, sponsored by Blue Earth Diagnostics.
- Completed
- Registry status
- Phase 3
- Development phase
- 221
- Enrollment target
NCT02680041 is a Phase 3 study that has completed, run by Blue Earth Diagnostics. The registered enrollment target is 221 participants.
The verdict
NCT02680041, a Phase 3 study, has completed, sponsored by Blue Earth Diagnostics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 221 participants
- Enrollment target
Study Summary
This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.
Interventions
- DRUG 18F-fluciclovine PET CT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2016-06-01 |
| Est. Completion | 2017-11-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02680041
The ClinicalTrials.gov registry entry for NCT02680041 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 221 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Blue Earth Diagnostics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 18F-fluciclovine PET CT is the first listed.
NCT02680041 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02680041 about?
NCT02680041 is a clinical study titled "18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment". This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage...
What is the current status of trial NCT02680041?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 221 participants. The study started on 2016-06-01. Estimated completion is 2017-11-01.
What interventions are being tested in trial NCT02680041?
The interventions under investigation include: 18F-fluciclovine PET CT (DRUG).
Who is sponsoring clinical trial NCT02680041?
This trial is sponsored by Blue Earth Diagnostics, which has 9 total clinical trials registered on ClinicalTrials.gov.
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