Abstract
BACKGROUND: Among women with breast cancer who undergo breast-conserving surgery (BCS), 20% to 25% require further surgery because of close or involved margins. Improved techniques are needed to assess resection margins. PURPOSE: The study aims were to assess the feasibility of the combined techniques of Cerenkov luminescence imaging-flexible autoradiography (CLI-FAR) to assess excision specimen margins in women undergoing BCS and to determine the diagnostic performance of intraoperative CLI-FAR imaging with postoperative histopathology as the reference standard. MATERIALS AND METHODS: Women undergoing BCS were recruited prospectively at a single center over 13 months. Patients were injected with 250 MBq ± 10 MBq of 18F-fluorodeoxyglucose, 145 minutes before surgery; the excised specimens were imaged intraoperatively. The surgically excised tumor was initially imaged using conventional x-ray, and margins suspected to be involved by tumor were then imaged using CLI-FAR. CLI-FAR imaging was performed using the LightPath system (Lightpoint), an in vitro diagnostic device designed to identify and locate positron-emitting radionuclides. Any suspicious margin underwent an immediate reexcision in the form of cavity shavings. Sensitivity, specificity, and positive and negative predictive values while considering histopathological assessment as the golden standard were used to assess the performance of CLI-FAR. RESULTS: In all, 54 specimens were imaged in 52 patients, with a total of 104 margins reviewed using CLI-FAR. The results showed a specificity of 97.8% (89/91; 95% confidence interval [CI], 95.0-100.6), sensitivity of 76.9% (10/13; 95% CI, 68.3-85.0), positive predictive value of 83.3% (10/12; 95% CI, 76.2-90.5), and negative predictive value of 96.7% (89/92; 95% CI, 93.3-100.2). In all, 8 patients had 10 positive margins on CLI-FAR imaging and were treated accordingly. CLI-FAR imaging reduced the reexcision rate by 69% (17.3/25). CONCLUSION: CLI-FAR imaging is a promising technique for intraoperative margin assessment in women undergoing BCS for invasive breast cancer.