Intraoperative Radiotherapy (IORT) for the Management of Carcinoma of the Breast: Use of Mammography, Ultrasonography,and Contrast-Enhanced Magnetic Resonance Imaging (CE-MRI) to Identify Candidates for IORT
Patients will be deemed eligible for immediate IORT if the invasive cancer lesion is
estimated to measure ≤ 3.0 centimeters maximum dimension by mammogram, ultrasound, and
CE-MRI and is thought to be resectable with WLE and clear surgical margins, with clinically
staged N0M0 disease, minimum age of 48, and histology of invasive ductal or lobular
carcinoma of the breast. The lesion size determined by imaging will be compared with lesion
size and surgical margin status obtained from the surgical pathology specimen to evaluate
the ability of mammography combined with ultrasound and CE-MRI to identify suitable
candidates for immediate IORT.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of Participants Receiving Additional Surgery Because of Positive or Close Margins as a Measure of the Accuracy of Pre-Operative Assessment
5 years
Yes
Peter V Chen, MD
Principal Investigator
Hoag Memorial Hospital Presbyterian
United States: Institutional Review Board
IORT
NCT01189851
June 2010
June 2018
Name | Location |
---|---|
Hoag Memorial Hospital Presbyterian - Cancer Center | Newport Beach, California 92658 |