Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123838
Status:
COMPLETED
Last Update Posted:
2016-04-28
First Post:
2005-07-22
Brief Title:
Positioning and Tracking the Prostate During External Beam Radiation
Sponsor:
Varian a Siemens Healthineers Company
Organization:
Varian a Siemens Healthineers Company
Study Overview
Official Title:
Beacon Transponder Implantation and Localization in the Prostate
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate a non-ionizing electromagnetic method to align the prostate treatment site for radiation therapy and to monitor its position throughout radiation therapy delivery The clinical study involves using an investigational device the Calypso 4D Localization System and requires permanent implantation of three small sensors called Beacon transponders in the prostate
Detailed Description:
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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None