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NCT03635866 · ClinicalTrials.gov registry record · NA
PET/MRI Study of Men With Highly Suspicious MRI Lesions That Showed no Clinically Significant Prostate Cancer Following MRI Fusion Targeted Biopsy
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT03635866: Completed NA study, sponsored by NYU Langone Health.
NCT03635866 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 36 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03635866, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study Summary
The principal aim of this study is to determine if PET/MRI imaging with 18-F fluciclovine (Axumin) identifies those men with false negative MRI fusion targeted biopsy (MRFTB) of PI-RADS 4 and 5 lesions. PI-RADS 4 and 5 MRI lesions are highly suspicious for clinically significant prostate cancer and require future repeat MRI imaging and possible repeat prostate biopsy depending on the results of the repeat MRI. Men, who had negative MRFTB within past 12 months of PI- RADS 4 or 5 MRI lesion will be included in this diagnostic study. The repeat MRI is standard of care at NYU Langone Health. The investigation aspect of the study is to perform an Axumin scan the same day as the MRI. Those men with persistent highly suspicious lesions will under MRFTB. The biopsy results will be compared with intensity of Axumin uptake within the prostate. The urologist will have the discretion to biopsy Axumin avid lesions not detected by MRI.
Primary Outcome
This will be measured by determining is if PET imaging with 18-F fluciclovine (Axumin) identifies those men with prior negative MRFTBs of PI-RADS 4 and 5 lesions who harbor clinically significant prostate cancer
Interventions
- DIAGNOSTIC_TEST Fluciclovine PET/MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-01-02 |
| Est. Completion | 2020-10-09 |
| Phase | NA |
What the finished NCT03635866 record still lists
NCT03635866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Fluciclovine PET/MRI is the first listed.
NCT03635866 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03635866 about?
NCT03635866 is a clinical study titled "PET/MRI Study of Men With Highly Suspicious MRI Lesions That Showed no Clinically Significant Prostate Cancer Following MRI Fusion Targeted Biopsy". The principal aim of this study is to determine if PET/MRI imaging with 18-F fluciclovine (Axumin) identifies those men with false negative MRI fusion targeted biopsy (MRFTB) of PI-RADS 4 and 5 lesions. PI-RADS 4 and 5 MRI lesions are highly suspicious for clinically significant prostate cancer and ...
What is the current status of trial NCT03635866?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2019-01-02. Estimated completion is 2020-10-09.
What interventions are being tested in trial NCT03635866?
The interventions under investigation include: Fluciclovine PET/MRI (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03635866?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03635866's enrollment target sits among peer trials
36 1541st of 2000 higher than 437 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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