Computed Tomography (CT) Scans Using CT-On-Rails™ to Pinp... | NCT00084526

ID	Type	Description	Link
P30CA006927	U.S. NIH Grant/Contract		View source
FCCC-03005

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Not provided

Completion Date

Feb 2007Actual

First Submitted Date

Jun 10, 2004

First Submission Date that Met QC Criteria

Jun 10, 2004

First Posted Date

Jun 11, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2010

Last Update Posted Date

Feb 12, 2010Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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 I/II 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 and/or 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Measure	Description	Time Frame
Validity of CT-on-rails software

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of definitive prostate cancer
Radiotherapy planned as treatment

PATIENT CHARACTERISTICS:

Age

Any age

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics

Surgery

Not specified

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Feigenberg, MD	Fox Chase Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fox Chase Cancer Center - Philadelphia		Philadelphia	Pennsylvania	19111-2497	United States

Name	Type	Description	Arm Group Labels	Other Names
computed tomography	Procedure
ultrasound imaging	Procedure

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation
D055585	Physical Phenomena

Measure	Description	Time Frame
Efficacy of fiducials
Treatment setup and target position uncertainties