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NCT03264456 · ClinicalTrials.gov registry record · Phase 1
Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI
A Phase 1 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT03264456 is a Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 18 participants.
The verdict
NCT03264456, a Phase 1 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
There is great need for improved preoperative imaging in men with high-risk prostate cancer. Investigators propose to develop and validate an optimized simultaneous PET/MRI protocol for local, regional and whole body preoperative staging in a single imaging session using the amino acid PET tracer, F-18 fluciclovine. Despite advances in the diagnosis and treatment of prostate cancer, the preoperative staging of men with prostate carcinoma (PCa) is currently problematic. Conventional imaging is falsely negative for regional lymph node metastases in a substantial fraction of men. In particular, approximately 35% of men with high-risk prostate cancer will have biochemical recurrence even after optimal surgical resection. A major benefit of simultaneous acquisition of a multiparametric prostate MRI (mpMRI) and F-18 fluciclovine PET includes having the patient undergo a single imaging study which provides both anatomic and molecular characterization of the tumor, including metastases which would potentially be missed by conventional anatomic imaging and size criteria. Additionally, simultaneous acquisition will improve co-registration of the PET and MR data which is valuable for small lesions and in anatomically complex regions. Although the use of fluciclovine in the characterization of the primary PCa remains to be established, the anatomic detail provided by conventional mpMRI will complement the detection of small volume metastatic disease by fluciclovine PET. Additionally, the use of hybrid PET/MRI technology allows for the assessment of dynamic tracer uptake and washout during the whole body and regional PET/MRI scan, which may demonstrate the ability to increase detection of the primary PCa on fluciclovine PET. If F-18 fluciclovine PET/MRI can reliably and accurately detect nodal metastases in high-risk prostate cancer patients, surgeons may use this new technology to develop new treatment algorithms for the optimal management of these patients.
Interventions
- DIAGNOSTIC_TEST [18F] Fluciclovine PET/MRI
- DRUG [18F] fluciclovine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-11-08 |
| Est. Completion | 2020-02-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03264456
The ClinicalTrials.gov registry entry for NCT03264456 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which [18F] Fluciclovine PET/MRI is the first listed.
NCT03264456 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03264456 about?
NCT03264456 is a clinical study titled "Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI". There is great need for improved preoperative imaging in men with high-risk prostate cancer. Investigators propose to develop and validate an optimized simultaneous PET/MRI protocol for local, regional and whole body preoperative staging in a single imaging session using the amino acid PET tracer, F...
What is the current status of trial NCT03264456?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2017-11-08. Estimated completion is 2020-02-13.
What interventions are being tested in trial NCT03264456?
The interventions under investigation include: [18F] Fluciclovine PET/MRI (DIAGNOSTIC_TEST), [18F] fluciclovine (DRUG).
Who is sponsoring clinical trial NCT03264456?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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