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Final Results of the Phase I Trial Evaluating the Feasibility of Intraoperative MRI for Margin Assessment During Breast Conserving Surgery in the Advanced Multimodality Image Guided Operating (AMIGO) Suite
*Melissa A Mallory1, *Yasuaki Sagara1, *Fatih Aydogan1,2, *Stephen DeSantis3, *Jayender Jagadeesan4, *Diana Caragacianu1, *Eva Gombos4, *Kirby Vosburgh4, *Ferenc A Jolesz4, Mehra Golshan1
1Department of Surgery, Brigham and Women's Hospital and Dana Farber Cancer Institute, Boston, MA;2Department of Breast Surgery, Cerrahpasa Medical School, Istanbul, Turkey3Breast Oncology Center, Dana Farber Cancer Institute, Boston, MA;4Department of Radiology, Brigham and Women’s Hospital, Boston, MA
Objective: Breast conserving surgery (BCS) followed by radiation is an option for early breast cancer, however reexcision rates to achieve clear margins can approach 40%. The feasibility of intraoperative magnetic resonance imaging (IMRI) for margin assessment in the Advanced Multimodality Image Guided Operating (AMIGO) suite was examined.
Design: Phase I clinical trial
Setting: National Comprehensive Cancer Network designated center (2012 -2015). BCS performed in AMIGO suite.
Patients: Stage I/II breast cancer candidates for BCS. Fifteen patients were enrolled, twelve completed the study
Interventions: Standard BCS in the AMIGO suite with IMRI was performed; enhancement concerning for residual disease was identified. Standard shave margins were excised post-imaging. IMRI assessments were correlated with pathology.
Main Outcome Measures: Feasibility based on procedural safety, sterility, duration and re-excisions.
Results: Twelve cases of BCS were completed and no complications or breaks in sterility occurred. Mean age was 54.5. Stage I disease was present in 75% of cases; stage II in 25%. Mean surgery duration was 113.7 minutes (range 91-146 min). No re-excisions were required for invasive cancer; two (16.7%) were performed for DCIS. 7/12 cases had pre-operative supine MRI; changes in the positional, dimensional, and structural metrics of tumors were observed between supine and prone positioning.
Conclusions: IMRI is feasible for real-time margin assessment in BCS. IMRI appears to detect residual invasive disease more readily than residual in situ disease. Tumor metrics on IMRI appear substantially altered between prone versus supine breast positioning. Additional studies are warranted to determine IMRI margin assessment accuracy and to characterize the effects of supine versus prone breast positioning.
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