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Intraoperative Mammography for Breast Cancer Surgery: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

Last updated: April 22, 2019
Project Number: RC1102-000
Product Line: Rapid Response
Research Type: Devices and Systems
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness of intraoperative imaging with mammography for breast cancer surgery?
  2. What is the cost-effectiveness of intraoperative imaging with mammography for breast cancer surgery?
  3. What are the evidence-based guidelines regarding intraoperative imaging for breast cancer surgery?

Key Message

Seven studies including one randomized controlled trial and six retrospective studies provided evidence of limited quality on the clinical effectiveness of intraoperative specimen mammography (IOSM).The clinical effectiveness evidence was sparse and results were inconclusive, primarily due to heterogeneity in the designs of the studies, lack of consistency in the terminology used to describe the interventions, and lack of details in describing the image acquisition techniques. Insufficient information was provided to ascertain whether comparable interventions were used across the studies. The interventions were identified as IOSM, digital IOSM, or intraoperative radiography and the comparators included standard specimen mammography, conventional specimen radiography, intraoperative ultrasound, gross specimen examination, and frozen section analysis. Furthermore, definitions of the outcome measures were not universal. Findings in support of IOSM were as follows: IOSM was as accurate as SSM in detecting target lesions within excised specimen in one randomized controlled trial involving 44 patients who primarily had invasive breast cancer; and in a retrospective database review, the use of IOSM in 26 patients to guide select shave margins in sonographically occult lesions significantly decreased re-excision rates relative to intraoperative ultrasound in 63 patients or gross specimen examination in 38 patients. Neither of these studies were conducted in Canada.No relevant economic analyses or evidence-based guidelines regarding the use of intraoperative mammography for breast cancer surgery were identified.Caution is advised in interpreting the information presented in this report due to the aforementioned heterogeneity among the studies, included studies’ lack of clarity in describing the interventions, and the paucity of evidence derived from the Canadian population. Economic evaluations and evidence-based guidelines are needed, and additional studies evaluating the comparative clinical effectiveness of IOSM in Canada would enhance the value of the clinical evidence.