CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
Fiducial marker placementprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00061347
NCT00061347Phase 1Completed

Trans-Rectal Placement of Prostatic Fiducial Markers Under MR-Guidance in Patients Receiving External Beam Radiotherapy for Prostate Cancer: A Pilot Study

National Cancer Institute (NCI)·interventional·Posted May 26, 2003·Updated Apr 23, 2018

In Brief

A Phase 1 clinical trial evaluating Fiducial marker placement for Prostate Cancer and Cancer. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 26, 2003
Enrollment StartMay 23, 2003
Primary CompletionMay 31, 2004
Study CompletionApr 19, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 23.1 years ago

Interventions

Fiducial marker placementprocedure

Placement of fidicual markers under MRI guidance for localization of radiaiton treatment