The Localisation Group

The iBRA-NET National Audit of localisation techniques for breast lesions

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A prospective audit of the outcomes of current techniques of breast localisation, which started with a prospective audit of Magseed® localisation of breast lesions compared to a control group of wire localised lesions (see Results section). The study is being facilitated through the Mammary Fold and the National Research Collaborative network.

 

We are currently running three prospective audits to evaluate the safety and efficacy of the Hologic LOCalizer™ device (audit launched in February 2021), the SCOUT® Radar Localisation device (audit launched in June 2021) and Sirius - Pintuition® (audit launched in May 2022). All users of these devices are welcome to participate, whether new or established. Registration links for either of these audits can be found above, and further information will be sent out following registration.

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Background:

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Excision of impalpable breast lesions is usually directed by preoperative wire placement into or adjacent to the target lesion. Wire localization has several disadvantages, most notably, displacement of the wire, and difficulty in the surgeon discerning accurately the position of the tip of the wire intraoperatively. Magseed®, LOCalizer™, Savi Scout® and Sirius - Pintuition® are alternative methods for localising impalpable breast cancers which may have advantages over wire localisation in many areas.

Between Feb 2019 and Sept 2020 as a group of breast surgeons we collected data on over 2000 procedures with wire localisation and Magseed®. This data was published March 2022 (reference below) and will act as comparative groups for future studies of other localisation techniques. The aim is that all innovative devices introduced are evaluated as they are used and we can together as a network establish safety and efficacy data collaboratively.

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Aims:

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1. Set up Key Performance Indicators to compare the outcomes of breast localisation devices (complete)

2. Describe the current practice of breast localisations (complete – see Results section).

3. Evaluate the outcomes of novel localisation techniques vs Wire localisation

4. To inform a future prospective trial in breast localisation surgery

5. To identify and disperse any learning points on new devices 

 

Primary outcome – Identification rate of index lesion

 

Secondary outcomes:

• Margin status

• Accuracy of placement

• Pathological weight of specimen

• Transcutaneous detection rate

• Reoperation rate

• Complications

• Cancellation rate on day of surgery

• Reason for cancellation on day of surgery

• Time of day of start of surgery

• Learning points from surgery

• Sensitivity of devices for bracketing lesions.

 

Results

National UK practice of breast localisations;

Somasundaram SK, Potter S, Elgammal S, Maxwell AJ, Sami AS, Down SK, Dave RV, Harvey J. Impalpable breast lesion localisation, a logistical challenge: results of the UK iBRA-NET national practice questionnaire. Breast Cancer Res Treat. 2020 Sep 10. doi: 10.1007/s10549-020-05918-6. Epub ahead of print. PMID: 32914355.

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Rajiv V. Dave, Emma Barrett, James Harvey et al. iBRA-NET Localisation Study collaborative, Wire- and magnetic-seed-guided localization of impalpable breast lesions: iBRA-NET localisation study, British Journal of Surgery, Volume 109, Issue 3, March 2022, Pages 274–282, https://doi.org/10.1093/bjs/znab443

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35 participating units

2300 patients

Lesion localisation rate – 99.8% Magseed® and 99.1% wire, equivalent complication rates, margins rates, re-excision rates, specimen weight and safety.

Summary: Magseed is highly accurate  and comparable with wire localisation when used in normal practice in a multi-centre manner.

 

iBRA Study Steering and Protocol Management Group

 

James Harvey (Chair), Suzanne Elgammal - Secretary, Nicola Barnes, Chris Holcombe, Shelley Potter – iBRA-NET chair, Edward St John - iBRA-NET innovation chair, Santosh Somasundaran – Protocol design and questionnaire design, Rajiv Dave- Redcap Lead, Anthony Maxwell – Radiology Lead, Senthurun Mylvaganam – Lead for Shared Learning, Amtul Sami, AB Kasem, Tahir Masudi, Sue Down, Yazan Masannat, Rob Milligan, Julia Henderson, Jenna Morgan, Mihir Chandarana

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iBRA Study Contact: localisationstudy@gmail.com