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NCT00924313 · ClinicalTrials.gov registry record · Phase 1
Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00924313: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00924313 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00924313, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Background: * Prostate cancers are difficult to see on most imaging studies such as X-rays, computed tomography (CT) scans, conventional magnetic resonance imaging (MRI) scans and conventional positron emission tomography (PET) scans. * An experimental radioactive tracer called 11C-acetate accumulates in prostate tumor cells and may help find prostate cancers more accurately than other imaging methods. Objectives: * To determine the accuracy of prostate tumor imaging using the tracer 11C-acetate. Eligibility: * Patients 18 years of age and older who are undergoing surgery for localized prostate cancer at the National Institutes of Health (NIH) Clinical Center. Design: * Patients have a positron emission tomography (PET scan). For this test, an intravenous (IV) line is placed in the patient's arm and the patient lies on a table inside the donut shaped scanner. (11)C-acetate is injected into the vein through the catheter and images of the lower pelvis and abdomen are obtained over 30 minutes. * Patients have an endorectal coil MRI scan. For this test, a tube is placed in the rectum, just behind the prostate, to increase the amount of signal received by the magnetic resonance (MR) unit. Other coils may be wrapped around the pelvis to further improve the quality of the scan. The patient lies on the scanning table for about 75 to 90 minutes while images are obtained. During the scan, a contrast agent called gadolinium is injected through an intravenous (IV) line to brighten the images.
Primary Outcome
Standard uptake values (SUV) measurements of 11C-acetate will be obtained in each sextant (e.g. region) on each patient. Sextant-specific malignancy will be determined pathologically based on a subsequent prostatectomy. Initially, on each patient, we will, average SUV measurements in tumor and non-tumor regions (i.e., sextants with malignancy and no malignancy, respectively). The patient average SUV measurements across tumors and non-tumor regions will then be compared using a paired t-test.
Interventions
- DRUG (C-11 Acetate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2008-09-10 |
| Est. Completion | 2011-04-19 |
| Phase | Phase 1 |
What the finished NCT00924313 record still lists
NCT00924313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which (C-11 Acetate) is the first listed.
NCT00924313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00924313 about?
NCT00924313 is a clinical study titled "Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer". Background: * Prostate cancers are difficult to see on most imaging studies such as X-rays, computed tomography (CT) scans, conventional magnetic resonance imaging (MRI) scans and conventional positron emission tomography (PET) scans. * An experimental radioactive tracer called 11C-acetate accumula...
What is the current status of trial NCT00924313?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2008-09-10. Estimated completion is 2011-04-19.
What interventions are being tested in trial NCT00924313?
The interventions under investigation include: (C-11 Acetate) (DRUG).
Who is sponsoring clinical trial NCT00924313?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00924313's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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