Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084526
Status:
COMPLETED
Last Update Posted:
2010-02-12
First Post:
2004-06-10
Brief Title:
Computed Tomography CT Scans Using CT-On-Rails to Pinpoint the Location of the Tumor in Treating Patients With Prostate Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Evaluation of Daily CT Scans Using CT on Rails for Localization in the Treatment of Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2010-02
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:
RATIONALE New imaging procedures such as CT-on-rails may improve the ability to pinpoint the location of the tumor and decrease radiation therapy damage to healthy tissue
PURPOSE This phase III trial is studying how well computed tomography CT scans using CT-on-rails work in pinpointing the location of the tumor in patients with prostate cancer
PURPOSE This phase III trial is studying how well computed tomography CT scans using CT-on-rails work in pinpointing the location of the tumor in patients with prostate cancer
Detailed Description:
OBJECTIVES
Primary
Validate the software for CT-on-rails by comparing prostate target localization via daily ultrasound vs computed tomography CT in patients undergoing radiotherapy for prostate cancer
Secondary
Determine the potential benefit of using fiducials in the prostate of patients undergoing daily CT scans andor ultrasounds for localization
Determine the intra- and inter-radiation treatment setup and target position uncertainties in terms of isocenter coordinates in space using both the ultrasound and CT scans compared to the coordinates of the isocenter determined at simulation in these patients
OUTLINE This is a pilot study
Phase I Patients undergo computed tomography CT using CT-on-rails twice weekly Patients undergo BAT ultrasound daily for prostate localization Patients undergo concurrent daily radiotherapy off study after imaging After radiotherapy treatment is complete patients continue to undergo scanning using CT-on-rails twice weekly
Phase II Patients undergo local anesthesia and surgical insertion of gold fiducial markers into the prostate After 1 week patients undergo a daily CT scan using CT-on-rails and bi-weekly BAT ultrasound Patients undergo daily radiotherapy off study after imaging After radiotherapy treatment is complete patients continue to undergo scanning using CT-on-rails twice weekly
PROJECTED ACCRUAL A total of 40 patients 20 per study phase will be accrued for this study
Primary
Validate the software for CT-on-rails by comparing prostate target localization via daily ultrasound vs computed tomography CT in patients undergoing radiotherapy for prostate cancer
Secondary
Determine the potential benefit of using fiducials in the prostate of patients undergoing daily CT scans andor ultrasounds for localization
Determine the intra- and inter-radiation treatment setup and target position uncertainties in terms of isocenter coordinates in space using both the ultrasound and CT scans compared to the coordinates of the isocenter determined at simulation in these patients
OUTLINE This is a pilot study
Phase I Patients undergo computed tomography CT using CT-on-rails twice weekly Patients undergo BAT ultrasound daily for prostate localization Patients undergo concurrent daily radiotherapy off study after imaging After radiotherapy treatment is complete patients continue to undergo scanning using CT-on-rails twice weekly
Phase II Patients undergo local anesthesia and surgical insertion of gold fiducial markers into the prostate After 1 week patients undergo a daily CT scan using CT-on-rails and bi-weekly BAT ultrasound Patients undergo daily radiotherapy off study after imaging After radiotherapy treatment is complete patients continue to undergo scanning using CT-on-rails twice weekly
PROJECTED ACCRUAL A total of 40 patients 20 per study phase will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FCCC-03005 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |