Trans-Rectal Placement of Prostatic Fiducial Markers Under MR-Guidance in Patients Receiving External Beam Radiotherapy for Prostate Cancer: A Pilot Study
Sponsor study identifier
Secondary identifiers
interventional
15
1 country
1
Study Start
May 23, 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 31, 2004
Actual (reported)Study Completion
April 19, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 19, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 23, 2003
Actual (reported)May 23, 2003
Date type not reportedThis date has not been verified as actual or estimated.
May 26, 2003
Actual (reported)May 31, 2004
Actual (reported)April 19, 2018
Actual (reported)To test the hypothesis that MRI guidance allows for accurate fiducial marker placement within the prostate
1, 3, 6, 12, 18, 24, 36, 48, and 60 months
To determine the toxicity of MR-Guided fiducial marker placement
1, 3, 6, 12, 18, 24, 36, 48, and 60 months
To gain preliminary experience using intraprostatic fiducial markers for daily set-up assessment and adjustment of external radiation beam targeting.
completion of study
To gain preliminary experience using intraprostatic fiducial markers for image fusion.
completion of study
To measure the magnitude of marker migration during the course of radiotherapy.
completion of study
To gather data on radiation therapy effects on prostate cancer patients treated at the NCI ROB.
completion of study
To gather data on the feasibility, tolerability, and effectiveness of local anesthetic injection along the neurovascular bundle under MRI guidance.
completion of study
Placement of fidicual markers under MRI guidance for localization of radiaiton treatment
Placement of fidicual markers under MRI guidance for localization of radiaiton treatment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Yu KK, Hricak H. Imaging prostate cancer. Radiol Clin North Am. 2000 Jan;38(1):59-85, viii. doi: 10.1016/s0033-8389(05)70150-0.
Knopp MV, Weiss E, Sinn HP, Mattern J, Junkermann H, Radeleff J, Magener A, Brix G, Delorme S, Zuna I, van Kaick G. Pathophysiologic basis of contrast enhancement in breast tumors. J Magn Reson Imaging. 1999 Sep;10(3):260-6. doi: 10.1002/(sici)1522-2586(199909)10:33.0.co;2-7.
Kevin A Camphausen, M.D.
National Cancer Institute (NCI)
15 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2003
First Posted
May 26, 2003
Study Start
May 23, 2003
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Kurhanewicz J, Vigneron DB, Hricak H, Narayan P, Carroll P, Nelson SJ. Three-dimensional H-1 MR spectroscopic imaging of the in situ human prostate with high (0.24-0.7-cm3) spatial resolution. Radiology. 1996 Mar;198(3):795-805. doi: 10.1148/radiology.198.3.8628874.
Primary Completion
May 31, 2004
Actual (reported)Study Completion
April 19, 2018
Actual (reported)Last Updated
April 23, 2018
Record last verified: 2018-04-19
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Source: ClinicalTrials.gov.
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