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NCT02297386 · ClinicalTrials.gov registry record · Phase 1
[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT02297386: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02297386 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02297386, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this study is to test the ability of a new PET scan radiotracer, called FDHT (stands for \[18F\] Dihydro-Testosterone), to better find and monitor prostate cancer. Radiotracers are a type of drug that carries small amounts of radioactivity that can be seen by the PET scanner. FDHT is a radiotracer that looks for a protein which is present in almost all prostate cancer cells. The investigators want to find out if we can find and monitor changes in cancer using a FDHT PET scan.
Primary Outcome
Enrolling 15 patients will provide 80% power to detect a 33% increase in the mean uptake (from 6 to 8) between the 2nd and the 3rd scans.
Interventions
- OTHER Blood draw
- DEVICE MRI
- DEVICE PET scan
- DRUG [18F] DIHYDRO-TESTOSTERONE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-11 |
| Est. Completion | 2018-08 |
| Phase | Phase 1 |
What the finished NCT02297386 record still lists
NCT02297386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Blood draw is the first listed.
NCT02297386 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02297386 about?
NCT02297386 is a clinical study titled "[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer". The purpose of this study is to test the ability of a new PET scan radiotracer, called FDHT (stands for \[18F\] Dihydro-Testosterone), to better find and monitor prostate cancer. Radiotracers are a type of drug that carries small amounts of radioactivity that can be seen by the PET scanner. FDHT is ...
What is the current status of trial NCT02297386?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2014-11. Estimated completion is 2018-08.
What interventions are being tested in trial NCT02297386?
The interventions under investigation include: Blood draw (OTHER), MRI (DEVICE), PET scan (DEVICE), [18F] DIHYDRO-TESTOSTERONE (DRUG).
Who is sponsoring clinical trial NCT02297386?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02297386's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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