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NCT04234399 · ClinicalTrials.gov registry record
Determination of the Diagnostic Detection Rate of Axumin (Fluciclovine) Digital PET/CT, Post-prostatectomy
A clinical trial, sponsored by University of Vermont.
- Terminated
- Registry status
- 22
- Enrollment target
NCT04234399: Clinical Trial study, sponsored by University of Vermont.
NCT04234399 is a clinical trial that was terminated before completion, run by University of Vermont. The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04234399 was terminated before completion, sponsored by University of Vermont.
- TERMINATED
- Registry status
- 22 participants
- Enrollment target
Study Summary
Fluciclovine F18 (Axumin) has been demonstrated to provide good delineation of recurrence of prostate cancer after definitive therapies. Fluciclovine in conjunction with the high-resolution digital Vereos (Phillips) PET-CT scanner may detect low volume recurrence in the prostatectomy bed or metastatic site (s). 20-40 % of men will suffer a biochemical recurrence of their prostate cancer after radical prostatectomy, depending on their final pathological staging, defined as a rising PSA \> 0.2 ng/ml. The ability to more accurately diagnose local recurrence (i.e. pelvis) or oligometastasis may lead to the opportunity of precise therapy of these sites with more durable cancer responses, less morbidity and potential cure in selective men after Radical Prostatectomy. The ability to diagnose widespread metastatic Prostate Cancer after Radical Prostatectomy, or disease that is inaccessible to local selective therapies would spare these men the cost and morbidity of inappropriate therapy. The diagnosis of true stage D0 Prostate Cancer (No objective evidence of metastases) in men after Radical Prostatectomy would yield improved overall and disease specific survival if Androgen Deprivation Therapy was initiated at its earliest stage. This would also obviate the need for inappropriate local therapies (i.e. pelvic radiotherapy). The aim is to compare the detection rate of standard of care (CT Pelvis/Abdomen, MR Pelvis, Bone Scan) with Fluciclovine PET/CT performed on the Vereos Philips Scanner. The study aims to compare the performance of Digital (high resolution) PET to CT/MRI/Bone scan rather than analog (lower resolution) PET. Prior studies have tested analog PET compared to other modalities. One could make an inference that if our study's Digital PET performs better than the performance of Analog PET in those studies, then Digital PET should have a better detection rate than Analog PET. However, investigators are not making a direct comparison between digital and Analog
Primary Outcome
Comparison of Fluciclovine digital PET/CT with standard of care imaging. Single time point.
Interventions
- DIAGNOSTIC_TEST Fluciclovine PET/CT using a digital PET/CT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-03-01 |
| Est. Completion | 2024-01-01 |
Why NCT04234399 stopped before completion
NCT04234399 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 22 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Fluciclovine PET/CT using a digital PET/CT is the first listed.
NCT04234399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04234399 about?
NCT04234399 is a clinical study titled "Determination of the Diagnostic Detection Rate of Axumin (Fluciclovine) Digital PET/CT, Post-prostatectomy". Fluciclovine F18 (Axumin) has been demonstrated to provide good delineation of recurrence of prostate cancer after definitive therapies. Fluciclovine in conjunction with the high-resolution digital Vereos (Phillips) PET-CT scanner may detect low volume recurrence in the prostatectomy bed or metastat...
What is the current status of trial NCT04234399?
This trial is currently terminated. The enrollment target is 22 participants. The study started on 2020-03-01. Estimated completion is 2024-01-01.
What interventions are being tested in trial NCT04234399?
The interventions under investigation include: Fluciclovine PET/CT using a digital PET/CT (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04234399?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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