Ultrasound Targeting for the Lumpectomy Cavity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00583843|
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : January 16, 2014
|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Procedure: Ultrasound|
Study participants will have weekly ultrasounds performed of the lumpectomy cavity to determine shift and volume changed from the initial treatment-planning CT to the time of the radiation boost (approximately 4 weeks). These ultrasounds are done prior to their weekly doctor's appointment with Radiation Oncology.
When it is time to perform the radiation boost (when the radiation is more targeted to the lumpectomy cavity), the ultrasound will be done daily with the participant in treatment position. The SonArray system used for the ultrasound-driven targeting for prostate cancer will be utilized. If the lumpectomy cavity is observed, the ultrasound suggested shifts will be noted and compared to the shifts needed for standard clinical set up.
Once the subject has completed radiation therapy, the study participation is complete.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Evaluation of Change in the Lumpectomy Cavity During Radiation Therapy by Weekly Ultrasound and by Daily Ultrasound During the Radiation Boost Dose|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||December 2011|
The group of women who are being followed by Ultrasound.
Ultrasound weekly during initial fields of radiation, and daily during the boost phase.
- Determine the volume change in lumpectomy cavity during the course of external beam radiation prior to delivery of the radiation boost. [ Time Frame: 7 weeks ]
- Determine by daily ultrasound if targeting of the CT-based boost field is inaccurate due to daily variation of subject position. [ Time Frame: 7 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583843
|United States, Iowa|
|The University of Iowa Hospitals & Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Geraldine Jacobson, MD MPH||The Department of Radiation Oncology|