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NCT03081884 · ClinicalTrials.gov registry record · Phase 2
Validation of FACBC for Detection of Metastasis Among High-risk Prostate Cancer Patients With Presumed Localized Disease
A Phase 2 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT03081884: Completed Phase 2 study, sponsored by Emory University.
NCT03081884 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03081884, a Phase 2 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
This study is for patients who have a high risk of metastatic prostate cancer (cancer that has spread outside of the prostate) who are going to have radical prostatectomy. The Anti-1-amino-3-\[18F\]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron emission tomography (PET) scan is a new imaging approach that has promising results in showing progression of cancer. The goal of this study is to determine if FACBC PET imaging will detect metastatic disease in patients with high risk prostate cancer who have negative conventional cross-sectional imaging such as computed tomography (CT) and/or magnetic resonance imaging (MRI), as well as bone scan and/or sodium fluoride PET. FACBC PET imaging may help detect metastatic prostate cancer in patients with newly diagnosed high risk primary prostate cancer and potentially improve staging of the cancer. Additionally, the researchers will compare the FACBC uptake in the prostate with uptake of FACBC detected in metastasis. They will also analyze and compare the prostate tissue, serum and urine parameters that are linked to higher rates of FACBC positivity.
Primary Outcome
The performance of FACBC PET/CT for diagnosing metastatic cancer was determined by confirming the FACBC PET/CT findings to the histological analysis of the lymph nodes.
Interventions
- DRUG FACBC PET-CT Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 2 |
What the finished NCT03081884 record still lists
NCT03081884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 1 intervention - of which FACBC PET-CT Imaging is the first listed.
NCT03081884 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03081884 about?
NCT03081884 is a clinical study titled "Validation of FACBC for Detection of Metastasis Among High-risk Prostate Cancer Patients With Presumed Localized Disease". This study is for patients who have a high risk of metastatic prostate cancer (cancer that has spread outside of the prostate) who are going to have radical prostatectomy. The Anti-1-amino-3-\[18F\]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron emission tomography (PET) scan is ...
What is the current status of trial NCT03081884?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2017-03-01. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT03081884?
The interventions under investigation include: FACBC PET-CT Imaging (DRUG).
Who is sponsoring clinical trial NCT03081884?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03081884's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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