In Vivo Dosimetry During Prostate Cancer Radiotherapy | NCT01307852

Studies
In Vivo Dosimetry During Prostate Cancer Radiotherapy

NCT01307852

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Apr 6, 2016Estimated

Enrollment

7Actual

Phase

Phase 1

Conditions

Prostate Disease

Interventions

Plastic Scintillation Detectors

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2011-00863	Registry Identifier	NCI CTRP
1R01CA120198-01A2	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2016

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 2011

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Mar 1, 2011

First Submission Date that Met QC Criteria

Mar 1, 2011

First Posted Date

Mar 3, 2011Estimated

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

Apr 4, 2016

Last Update Posted Date

Apr 6, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical research study is to learn if a rectal balloon with attached radiation detectors can be used to help researchers monitor the dose of external beam radiation that is delivered to the prostate during treatment. This may help researchers better understand the side effects of radiation therapy, such as rectal bleeding, and may lead to changes in treatment planning or treatment delivery.

Detailed Description

As a part of your standard of care, you will have external beam radiation therapy. You will have a computerized tomography (CT) scan of the pelvis before the external beam radiation therapy.

For the CT scan, you will be given an enema to empty your bowel, and you will drink about 16 to 24 ounces of water to fill your bladder

A rectal balloon will then be inserted into your rectum and filled with either air or water. You will then have the CT scan. The CT scan should take about 45 minutes.

If you agree to take part in this study, very thin (millimeter-sized) radiation detectors will be attached to the rectal balloon during each of two CT scans per week you will have while you are receiving radiation. You may have additional CT scans (without the detector) each week if your doctor thinks it is needed.

The doses read by the radiation detectors will be compared to the doses that you were originally scheduled to receive after each radiation treatment and at the end of the study.

You will be off study after your final radiation treatment using the rectal balloon.

This is an investigational study. Up to 15 patients will take part in this study. All will be enrolled at MD Anderson.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
In Vivo Dosimetry	Experimental	Modified endorectal device capable of real-time dose measurement during prostate radiation therapy	Device: Plastic Scintillation Detectors

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plastic Scintillation Detectors	Device	Radiation detectors attached to rectal balloon for each CT scan done during each radiation treatment. Treatment delivery Monday through Friday for 7 weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of True In Vivo Radiation to Rectal Wall During Prostate Radiotherapy	Twice a week in vivo measurements of radiation dose absorbed by the rectal wall during intensity-modulated radiotherapy (IMRT) of prostate.	Twice a week for 7 week treatment.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patients with prostate cancer who are undergoing routine radiation therapy for their prostate cancer, including post-prostatectomy patients.
The selection criteria will be limited to the patient's ability to withstand insertion of a rectal balloon and his willingness to participate in the study.
We will choose patients undergoing photon and proton treatments.

Exclusion Criteria:

N/A

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sam Beddar, PHD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas MD Anderson Cancer Center		Houston	Texas	77030	United States

References Module

Citations

Not provided

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases