Positioning and Tracking the Prostate During External Beam Radiation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00123838|
Recruitment Status : Completed
First Posted : July 26, 2005
Last Update Posted : April 28, 2016
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Device: Calypso® 4D Localization System|
The goal for prostate radiation therapy is to give a high dose of radiation to the prostate and a minimal dose to the healthy tissue around the prostate. It is well known that the prostate moves slightly within the pelvis and that its position varies a few millimeters from day to day. There are several methods used to position the body and the prostate accurately at the beginning of each radiation therapy session.
One of the standard methods is to permanently implant small markers (gold spheres or cylinders) in the prostate and use x-rays in the radiation therapy treatment room to determine whether the markers are in the correct position. If the markers are in the correct position, then the assumption is that the prostate also is in the correct position. If the markers are not in the correct position on the x-ray, then the table that the patient lies on can be shifted so that the markers are in the right place.
In this study the Beacon® transponder will be used in place of the standard gold marker. During the radiation therapy visits, the patient position in the treatment room will be corrected using the Beacon transponder with an investigational system, called the Calypso® 4D Localization System. The Calypso system consists of a flat panel, placed over the pelvis and connected to a computer, which monitors the position of the Beacon transponders within the prostate. During five radiation therapy appointments and one extra visit, the position of the markers in the prostate will be confirmed with x-rays.
The Beacon transponder is a small glass cylinder that contains a tiny electrical circuit. The glass vial is completely sealed and separates the internal components (i.e., the electrical circuit) from the rest of the body. The glass vial is approximately one-third of one inch long and one-tenth of one inch in diameter. Three Beacon transponders will be implanted in the prostate. They will be permanently implanted.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Beacon® Transponder Implantation and Localization in the Prostate|
|Study Start Date :||July 2005|
|Primary Completion Date :||September 2008|
|Study Completion Date :||September 2008|
Experimental: Single Group Assignment
Calypso® 4D Localization System
Device: Calypso® 4D Localization System
Localization of prostate irradiation.
- Radiographic verification of at least five of approximately 40 radiation treatment days [ Time Frame: 8 weeks ]
- Patient Preference Questionnaire and SF 36 Health Survey at five radiation treatment days [ Time Frame: 8 week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123838
|United States, Arizona|
|Scottsdale Healthcare - Osborn|
|Scottsdale, Arizona, United States, 85260|
|United States, California|
|Sharp Memorial Hospital|
|San Diego, California, United States, 92123|
|United States, Florida|
|M.D. Anderson Cancer Center Orlando|
|Orlando, Florida, United States, 32806|
|United States, Nebraska|
|The Nebraska Medical Center|
|Omaha, Nebraska, United States, 68105|
|United States, Ohio|
|The Cleveland Clinic|
|Cleveland, Ohio, United States, 44192|
|Study Director:||Lisa Levine, Ph.D.||Varian Medical|