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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.

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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

FieldValue
Enrollment Target 15 participants
Start Date 2003-05-23
Est. Completion 2018-04-19
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00061347 record still lists

NCT00061347 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower).

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 a single indexed study location in 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.

Similar trials for Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00061347's enrollment target sits among peer trials

15 687th of 735 higher than 44 of 735 other Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer 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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Source: ClinicalTrials.gov NCT00061347, the US trial registry maintained by the National Library of Medicine. NCT00061347 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.