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NCT04266392 · ClinicalTrials.gov registry record · Early Phase 1
Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand
A Early Phase 1 study, sponsored by Stony Brook University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT04266392: Completed Early Phase 1 study, sponsored by Stony Brook University.
NCT04266392 is a Early Phase 1 study that has completed, run by Stony Brook University. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04266392, a Early Phase 1 study, has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Eligible patients have prostate cancer that was treated with surgery or radiation therapy for localized disease and there is evidence of biochemical recurrence and/or metastases on conventional imaging.The objective of this study is to assess the performance in detection of prostate cancer of a new positron emission tomography (PET) radiotracer for prostate cancer (\[18F\]-DCFPyl) combined with magnetic resonance imaging (MRI). Results of tracer uptake and MRI image features as whole body PET/MRI and dedicated pelvic/prostate PET/MRI, alone and together, will be correlated and compared to detection of lesions on conventional imaging modalities. Additionally, if the patient undergoes a biopsy as standard of care, image features will correlate directly with histopathological findings.Validation of this radiotracer can potentially lead to its use as a standard of care for future imaging and improve diagnosis and treatment guidance.This drug is not approved by the Food and Drug Administration (FDA) and is therefore considered experimental.There will be 20 subjects enrolled in this study; all of these patients will be enrolled at Stony Brook University Medical Center.
Primary Outcome
Compare \[18F\]DCFPyL PET imaging combined with whole body magnetic resonance imaging (MRI) and multiparametric pelvic/prostate MRI to conventional imaging modalities (CIM)--such as 99mTc-methylene diphosphonate bone scan (BS) and contrast-enhanced CT (CECT) of the abdomen and pelvis, or a newly approved PET imaging agent F-18 Fluciclovine, for the localization and determination of extent of recurrent/metastatic disease in patients with biochemical recurrence of prostate cancer or evidence of re
Interventions
- DRUG [18F]-DCFPyl Ligand
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-12-16 |
| Est. Completion | 2021-10-15 |
| Phase | Early Phase 1 |
What the finished NCT04266392 record still lists
NCT04266392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which [18F]-DCFPyl Ligand is the first listed.
NCT04266392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04266392 about?
NCT04266392 is a clinical study titled "Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand". Eligible patients have prostate cancer that was treated with surgery or radiation therapy for localized disease and there is evidence of biochemical recurrence and/or metastases on conventional imaging.The objective of this study is to assess the performance in detection of prostate cancer of a new ...
What is the current status of trial NCT04266392?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2019-12-16. Estimated completion is 2021-10-15.
What interventions are being tested in trial NCT04266392?
The interventions under investigation include: [18F]-DCFPyl Ligand (DRUG).
Who is sponsoring clinical trial NCT04266392?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04266392's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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