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NCT00061347 · ClinicalTrials.gov registry record · Phase 1
Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment
A Phase 1 study of Prostate Cancer and Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT00061347: Completed Phase 1 study of Prostate Cancer and Cancer, sponsored by National Cancer Institute (NCI).
NCT00061347 is a Phase 1 study of Prostate Cancer and Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 15 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00061347, a Phase 1 study of Prostate Cancer and Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
To effectively treat prostate cancer, doctors need an accurate view (via X-rays) of the prostate gland during radiation therapy. To help improve this view, doctors may insert gold markers called fiducials into the prostate by placing hollow gold needles through the rectum and moving a fiducial through each needle. The purpose of the study is to determine whether an MRI scan can help doctors improve their placement of these needles. Fifteen men will participate in this study. Patients will take the antibiotic levofloxacin for two days prior to the placement of the fiducials, then will have a small enema and another dose of the antibiotic on the morning of the procedure. After being anesthetized, patients will have an antenna-like tube placed into the rectum and have MRI images taken of the area. The doctor will then use these scans to place four fiducials into the prostate. The procedure will require approximately 45 minutes. Patients will be allowed to go home the same day of the procedure, which will be followed by a seven-week course of standard radiation therapy. Prior to their participation in this study, patients will undergo the following evaluations: a physical exam, blood work, urine tests, and, if appropriate, an MRI or bone scan.
Conditions Studied
Interventions
- PROCEDURE Fiducial marker placement
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2003-05-23 |
| Est. Completion | 2018-04-19 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00061347
The ClinicalTrials.gov registry entry for NCT00061347 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Fiducial marker placement is the first listed.
NCT00061347 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00061347 about?
NCT00061347 is a clinical study titled "Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment". To effectively treat prostate cancer, doctors need an accurate view (via X-rays) of the prostate gland during radiation therapy. To help improve this view, doctors may insert gold markers called fiducials into the prostate by placing hollow gold needles through the rectum and moving a fiducial throu...
What is the current status of trial NCT00061347?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2003-05-23. Estimated completion is 2018-04-19.
What conditions does trial NCT00061347 study?
This clinical trial studies the following conditions: Prostate Cancer, Cancer.
What interventions are being tested in trial NCT00061347?
The interventions under investigation include: Fiducial marker placement (PROCEDURE).
Who is sponsoring clinical trial NCT00061347?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00061347 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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