BJS open · 2026
The iBRA-NET localization study: international IDEAL 2a/2b multicentre cohort study comparing the safety and effectiveness of wire- and radar-guided localization for impalpable breast lesions.
СтатьяМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Dave Rajiv V, Morgan Jenna, Lowes Simon, Milligan Robert, Foster Rachel, Barrett Emma, Carmichael Amtul R, Elgammal Suzanne, St John Edward, Holcombe Chris, Masannat Yazan, Potter Shelley, Krizak Suzanne, Raghavan Vidya, Harvey James, iBRA-NET Localisation Study collaborative, on behalf of
Аннотация
BACKGROUND: Wire-guided localizations have been the historical standard for breast lesion localization; however, they have logistical constraints and can dislodge in the preoperative period. Radar-guided localization has the potential to uncouple localization from the day of surgery, but the technique needs to be evaluated in a direct comparison with wire-guided localization to ensure efficacy and safety.
METHODS: The iBRA-NET localization study is a prospective platform IDEAL 2a/2b study comparing wire-guided localization with new generation localization devices. This arm describes SCOUT® radar localization for impalpable breast lesions performed between June 2021 and December 2024, compared with a historical cohort of wire-guided localization performed between August 2018 and August 2020. Primary outcome was identification of the index lesion in the excision specimen. Secondary endpoints included safety (complications), margin re-excision, magnetic resonance imaging bloom size, and specimen weight.
RESULTS: Data were accrued from 1297 radar localized patients in 27 units. Index lesion identification was 95.2% in radar-guided excisions versus 99.1% in wire-guided excisions (P = 0.001). In a sensitivity analysis excluding patients receiving neoadjuvant chemotherapy, identification rates were 98.9% versus 99.6% (P = 0.114). For a subset of patients having a simple lumpectomy for a unifocal, unilateral breast lesion with no neoadjuvant treatment (1627), positive margins were seen in the main excision specimen in 1003 (15.0%) wire-guided versus 624 (9.0%) radar-guided excisions (P < 0.001). Re-excision was required in 131 (13.2%) wire-guided versus 91 (14.7%) radar-guided excisions (P = 0.442). There was a significant difference in specimen weight/size2 (0.138 g/mm2 wire-guided localization versus 0.182 g/mm2 radar; P < 0.001). The median start time for surgery was earlier in the day for radar-guided localizations compared with wire-guided (12:27 versus 13:40; P < 0.001). All radar placements in axillary nodes (13) led to successful nodal retrieval.
CONCLUSION: SCOUT® radar localizations are a safe and effective localization technique in both the breast and axilla, with outcomes comparable to wires. There were demonstrable logistical advantages in operative start time when using a radar reflector.
METHODS: The iBRA-NET localization study is a prospective platform IDEAL 2a/2b study comparing wire-guided localization with new generation localization devices. This arm describes SCOUT® radar localization for impalpable breast lesions performed between June 2021 and December 2024, compared with a historical cohort of wire-guided localization performed between August 2018 and August 2020. Primary outcome was identification of the index lesion in the excision specimen. Secondary endpoints included safety (complications), margin re-excision, magnetic resonance imaging bloom size, and specimen weight.
RESULTS: Data were accrued from 1297 radar localized patients in 27 units. Index lesion identification was 95.2% in radar-guided excisions versus 99.1% in wire-guided excisions (P = 0.001). In a sensitivity analysis excluding patients receiving neoadjuvant chemotherapy, identification rates were 98.9% versus 99.6% (P = 0.114). For a subset of patients having a simple lumpectomy for a unifocal, unilateral breast lesion with no neoadjuvant treatment (1627), positive margins were seen in the main excision specimen in 1003 (15.0%) wire-guided versus 624 (9.0%) radar-guided excisions (P < 0.001). Re-excision was required in 131 (13.2%) wire-guided versus 91 (14.7%) radar-guided excisions (P = 0.442). There was a significant difference in specimen weight/size2 (0.138 g/mm2 wire-guided localization versus 0.182 g/mm2 radar; P < 0.001). The median start time for surgery was earlier in the day for radar-guided localizations compared with wire-guided (12:27 versus 13:40; P < 0.001). All radar placements in axillary nodes (13) led to successful nodal retrieval.
CONCLUSION: SCOUT® radar localizations are a safe and effective localization technique in both the breast and axilla, with outcomes comparable to wires. There were demonstrable logistical advantages in operative start time when using a radar reflector.