Pilot Study to Evaluate In Vivo Plastic Scintillation Detectors for Real-Time Radiation Dosimetry During Prostate Cancer Radiotherapy
18 Years
N/A
Male
Prostate Disease
Trial Information
Pilot Study to Evaluate In Vivo Plastic Scintillation Detectors for Real-Time Radiation Dosimetry During Prostate Cancer Radiotherapy
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 10 patients will take part in this study. All will
be enrolled at MD Anderson.
Inclusion Criteria:
1. Any patients with prostate cancer who are undergoing routine radiation therapy for
their prostate cancer, including post-prostatectomy patients.
2. 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.
3. We will choose patients undergoing photon and proton treatments.
Exclusion Criteria:
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Measurement of True In Vivo Radiation to Rectal Wall During Prostate Radiotherapy
Outcome Description:
Twice a week in vivo measurements of radiation dose absorbed by the rectal wall during intensity-modulated radiotherapy (IMRT) of prostate.
Outcome Time Frame:
Twice a week for 7 week treatment.
Safety Issue:
No
Principal Investigator
Sam Beddar, PHD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2010-0427
NCT ID:
NCT01307852
Start Date:
November 2011
Completion Date:
Related Keywords:
- Prostate Disease
- Fiber optic radiation detectors
- Enhanced endorectal balloon
- Radiation treatment
- Radiotherapy
- External beam radiation
- Dosimetry
- Prostatic Diseases
- Prostatic Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
