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NCT00917865 · ClinicalTrials.gov registry record · Phase 2
FACBC Positron Emission Tomography/Computed Tomography(PET/CT) Used in the Diagnosis of Primary Prostate Cancer
A Phase 2 study, sponsored by David M. Schuster, MD.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00917865: Clinical Trial Phase 2 study, sponsored by David M. Schuster, MD.
NCT00917865 is a Phase 2 study that was terminated before completion, run by David M. Schuster, MD. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00917865, a Phase 2 study, was terminated before completion, sponsored by David M. Schuster, MD.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this research project is to test if a compound (chemical substance) has a natural tendency to go to prostate cancer. This compound has a small amount of radioactivity attached to it and is called a radiotracer. The name of the radiotracer is FACBC and can be detected on a special imaging device called a PET scanner (positron emission tomography). The radiotracer is treated in the body much like an amino acid which is a nutrient required for normal functioning. Tumors also use these nutrients. Earlier studies have shown that this radiotracer may be able to detect prostate cancer. The investigators will perform a study with 20 patients in whom they know have prostate cancer after a biopsy and who are scheduled for an operation in which the prostate is removed and the nearby lymph nodes are examined. This operation is called prostatectomy. The investigators think that this radiotracer can help us determine where exactly the prostate cancer is present in the prostate or if it has spread. This information may be useful in the future to help with other non-surgical therapy such as radiation beam therapy. The investigators will compare the results of the FACBC PET scan to the results of the pathology analysis of the removed prostate. In this way the investigators can determine how good a test FACBC PET is for finding out where and if prostate cancer is located in the prostate or nearby lymph nodes. The investigators will also do more advanced analysis on the biopsy samples to see if they can tell why FACBC goes into prostate cancer cells. This radiotracer has been tested in over 100 human subjects without incident. It has also been chosen by the National Institutes of Health (NIH) as a promising radiotracer. The NIH is funding this study.
Interventions
- DRUG anti [18F]FACBC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2008-04 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00917865
The ClinicalTrials.gov registry entry for NCT00917865 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is David M. Schuster, MD, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which anti [18F]FACBC is the first listed.
NCT00917865 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00917865 about?
NCT00917865 is a clinical study titled "FACBC Positron Emission Tomography/Computed Tomography(PET/CT) Used in the Diagnosis of Primary Prostate Cancer". The purpose of this research project is to test if a compound (chemical substance) has a natural tendency to go to prostate cancer. This compound has a small amount of radioactivity attached to it and is called a radiotracer. The name of the radiotracer is FACBC and can be detected on a special imag...
What is the current status of trial NCT00917865?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2008-04. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00917865?
The interventions under investigation include: anti [18F]FACBC (DRUG).
Who is sponsoring clinical trial NCT00917865?
This trial is sponsored by David M. Schuster, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
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