Volume 72, Issue 2 , Pages 597-604, 1 October 2008
The Observed Variance Between Predicted and Measured Radiation Dose in Breast and Prostate Patients Utilizing an In Vivo Dosimeter
Purpose
Report the results of using a permanently implantable dosimeter in radiation therapy: determine specific adverse events, degree of migration, and acquire dose measurements during treatment to determine difference between expected and measured dose.
Methods and Materials
The Dose Verification System is a wireless, permanently implantable metal–oxide semiconductor field-effect transistor dosimeter using a bidirectional antenna for power and data transfer. The study cohort includes 36 breast (33 patients received two devices) and 29 prostate (21 patients received two devices) cancer patients. A total of 1,783 and 1,749 daily dose measurements were obtained on breast and prostate patients, respectively. The measurements were compared with the planned expected dose. Biweekly computed tomography scans were obtained to evaluate migration and the National Cancer Institute's Common Toxicity Criteria, version 3, was used to evaluate adverse events.
Results
Only Grade I/II adverse events of pain and bleeding were noted. There were only four instances of dosimeter migration of >5 mm from known factors. A deviation of ≥7% in cumulative dose was noted in 7 of 36 (19%) for breast cancer patients. In prostate cancer patients, a ≥7% deviation was noted in 6 of 29 (21%) and 8 of 19 (42%) during initial and boost irradiation, respectively. The two patterns of dose deviation were random and systematic. Some causes for these differences could involve organ movement, patient movement, or treatment plan considerations.
Conclusions
The Dose Verification System was not associated with significant adverse events or migration. The dosimeter can measure dose in situ on a daily basis. The accuracy and utility of the dose verification system complements current image-guided radiation therapy and intensity-modulated radiation therapy techniques.
Implantable dosimeter, In situ radiation, Dosimetry prostate and breast cancer
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Conflict of Interest: The following participants are associated with Sicel Technologies, Inc., the manufacturer of the implantable dosimeter used in the study: Charles W. Scarantino, M.D., Ph.D., is a cofounder of the company, medical director for the company, and member of the Board of Directors; Gloria P. Beyer, Ph.D., is an officer of the company; Robert D. Black, Ph.D., was an officer of the company during the study and a consultant for the company at the time of data analysis; Natasha Bolick is an employee of the company.
The study analyzes the data obtained from a Food and Drug Administration–approved study protocol. The data used and presented in this research were collected, monitored, and managed in accordance with the FDA's adopted ICH Guideline for Good Clinical Practice and 21 CFR Parts 50, 54, 56, and 812 and 45 CFR Parts 160 and 164.
Supported in part by NCI Grant R21CA 97859.
PII: S0360-3016(08)02465-6
doi:10.1016/j.ijrobp.2008.05.058
© 2008 Elsevier Inc. All rights reserved.
Volume 72, Issue 2 , Pages 597-604, 1 October 2008
