Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 10:58 PM
Study NCT ID:
NCT00921193
Status:
COMPLETED
Last Update Posted:
2011-03-30
First Post:
2009-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Radiation Therapy Positioning System (RTPS) in Patients With Localized Prostate Cancer
Sponsor:
Navotek Medical, Ltd.
Organization:
Study Overview
Official Title:
Evaluation of Radiation Therapy Positioning System (RTPS) in Patients With Localized Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2011-03
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 study aims to evaluate the safety and performance of the RTPS in patients with localized prostate cancer.The RTPS is an investigational device and requires permanent implantation of a small radioactive fiducial, called the Blip, in the prostate.
Detailed Description:
The high precision of planned radiotherapy treatments requires accurate positioning of the prostate in order to ensure that the tightly conformed dose distribution does not miss the prostate and result in either significant tumor underdosage, an increased dose to the rectum or bladder, or both. Precise delivery has been addressed using a variety of pre-treatment localization systems. The most direct localization of the prostate involves the use of ultrasound, computed tomography (CT), or radiography of permanently implanted fiducial markers.
In this study the safety and performance of a novel investigational tracking system will be evaluated. The Radiation Therapy Positioning System (RTPS) is a radioactive tracking system integrated into the radiotherapy set-up workflow. The System is composed of the Clinical Positioning System (CPS) and a radioactive soft tissue implanted fiducial (Blip), which is permanently implanted in the prostate. By tracking the implanted Blip, the CPS can monitor positional changes prior to and during the treatment.
The accuracy of the RTPS localization will be compared to the CBCT in at least 5 radiation therapy sessions per patient.
In this study the safety and performance of a novel investigational tracking system will be evaluated. The Radiation Therapy Positioning System (RTPS) is a radioactive tracking system integrated into the radiotherapy set-up workflow. The System is composed of the Clinical Positioning System (CPS) and a radioactive soft tissue implanted fiducial (Blip), which is permanently implanted in the prostate. By tracking the implanted Blip, the CPS can monitor positional changes prior to and during the treatment.
The accuracy of the RTPS localization will be compared to the CBCT in at least 5 radiation therapy sessions per patient.
Study Oversight
Has Oversight DMC:
False
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?: