Specimen PET-CT Imaging for Intraoperative Margin Assessment in Early-Stage Breast Cancer: The BrIMA Nonrandomized Clinical Trial

Göker M, Hahn M, Kraemer XE, et al. Specimen PET-CT Imaging for Intraoperative Margin Assessment in Early-Stage Breast Cancer: The BrIMA Nonrandomized Clinical Trial. JAMA Surg. 2026;161(8):785–794. doi:10.1001/jamasurg.2026.2090

Positive margins remain a persistent challenge in breast-conserving surgery (BCS), occurring in 12–30% of cases and increasing local recurrence risk. This multicentre, nonrandomised interventional trial (NCT04999917), sponsored by XEOS Medical, maker of the AURA10 specimen PET-CT system used in the study, was conducted across six European breast centres from June 2022 to March 2025 and is described as the largest prospective multicentre evaluation of specimen PET-CT to date. It evaluated whether intraoperative specimen PET-CT could improve margin assessment for invasive ductal carcinoma.

In a cohort of 148 female patients (median age 65 years; median tumour size 17 mm), patients received low-dose intravenous 18F-FDG (0.8 MBq/kg) before excision. Specimens were then imaged intraoperatively with a dedicated PET-CT scanner, with surgeons re-excising tissue in real time when margins appeared suspicious, using histopathology as the reference standard.

For the invasive component of invasive ductal carcinoma, margin clearance rose from 83.3% (no intraoperative assessment) to 86.9% (standard techniques) to 95.2% with PET-CT (P<.001 vs no assessment). Across the full cohort, success rates improved similarly: 76.4% to 81.8% to 91.9% with PET-CT (P<.001 vs no assessment; P=.009 vs standard techniques). Final positive margin and reoperation rates were reported as secondary outcomes.

These findings suggest specimen PET-CT could meaningfully reduce re-excision after BCS. However, the nonrandomised, sequential-cohort design, industry sponsorship, and absence of reported cost data leave results vulnerable to confounding by centre experience and temporal practice change. An accompanying editorial calls for randomised comparison against competing techniques (radiofrequency spectroscopy, fluorescence imaging, cavity shave margins) and cost-effectiveness data before wider adoption.

Summary Author: Mr Laszlo Romics, Consultant Oncoplastic Breast and General Surgeon, NHS Greater Glasgow and Clyde, and Honorary Clinical Senior Lecturer, University of Glasgow