BCL vs WL Guided Surgery for Breast Cancer

Recruiting at 19 trial locations

Overseen By Jodie Ploetz, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: CairnSurgical, Inc.

Disqualifiers: Pacemaker, Claustrophobia, Kidney disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

448 Participants Needed

Trial Summary

What is the purpose of this trial?

This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Subjects will be randomized to breast conserving surgery (BCS) utilizing either the BCL or wire localization (WL) to guide surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving or planning to receive chemotherapy, you would not be eligible for this trial.

What data supports the effectiveness of this treatment for breast cancer?

Research shows that wire-guided localization (WL) is a popular and effective technique for breast cancer surgery, helping to minimize the need for additional surgeries and improve cosmetic outcomes. Studies also suggest that using multiple wires (bracketing) can reduce the amount of tissue removed without affecting the success of the surgery. ^{1 2 3 4 5}

Is BCL or WL guided surgery for breast cancer safe for humans?

The Breast Cancer Locator (BCL) and Wire Localization (WL) techniques have been used in breast-conserving surgeries, and while the studies focus on effectiveness and surgical outcomes, they do not report specific safety concerns, suggesting these methods are generally considered safe for human use. ^{1 2 3 4 6}

How is the BCL guided partial mastectomy treatment different from other breast cancer treatments?

The BCL guided partial mastectomy is unique because it uses a Breast Cancer Locator (BCL) to guide the surgery, which may improve precision compared to traditional wire localization (WL) methods. This approach aims to reduce the need for re-excision and improve cosmetic outcomes by minimizing the volume of tissue removed. ^{1 2 3 4 5}

Research Team

Jennifer Gass, MD

Principal Investigator

Women & Infants Hospital

Eligibility Criteria

This trial is for women over 18 with non-palpable invasive breast cancer or DCIS, visible on MRI, at least 1 cm in size. Candidates must not have severe claustrophobia, metal implants incompatible with MRI, allergies to device materials or gadolinium contrast, and should not be pregnant. The tumor should be unifocal without multicentric tumors more than 2 cm away.

Inclusion Criteria

Ability to voluntarily provide informed consent

My surgeon needs special techniques to locate my tumor because it can't be felt by hand.

The tumor shows up more clearly on a special type of breast MRI scan.

Exclusion Criteria

Before joining the study, women who could get pregnant will need to take a pregnancy test.

I am severely allergic to gadolinium-based contrast.

I need more than 2 wires to locate my tumor if I receive standard treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo breast conserving surgery (BCS) using either Breast Cancer Locator (BCL) or Wire Localization (WL) for surgical guidance

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of positive margin rate and re-excision rate

18 months

Treatment Details

Interventions

• Breast Cancer Locator (BCL) guided partial mastectomy
• Wire Localized (WL) partial mastectomy

Trial Overview The study compares two methods of guiding surgery for breast cancer: the Breast Cancer Locator (BCL) and traditional Wire Localization (WL). Participants will undergo a partial mastectomy using one of these techniques determined by random assignment.

Participant Groups

Group I: Breast Cancer Locator (BCL) Experimental Treatment 1 Intervention

Subject randomized to BCL surgical guidance to perform partial mastectomy

Group II: Wire Localization (WL) Active Control 1 Intervention

Subject randomized to WL surgical guidance to perform partial mastectomy

Breast Cancer Locator (BCL) guided partial mastectomy is already approved in United States, European Union for the following indications:

Approved in United States as Breast Cancer Locator for:

• Non-palpable invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Approved in European Union as Breast Cancer Locator for:

• Non-palpable invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Who Is Running the Clinical Trial?

CairnSurgical, Inc.

Lead Sponsor

Trials

3

Recruited

530+

Findings from Research

In a study of 148 breast cancer patients, the combination of oncoplastic breast-conserving surgery (OBCS) and tailored wire-guided localization (WL) resulted in a 13.5% rate of positive margins, indicating effective surgical precision.

The study found that multifocality in tumors significantly increased the likelihood of affected margins (odds ratio 4.67), highlighting the importance of individualized surgical planning to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncoplastic breast conserving surgery with tailored needle-guided excision. Hernanz, F., González-Noriega, M., Sánchez, S., et al.[2022]

Bracketing wire-guided localization (BWL) significantly reduces the amount of healthy breast tissue removed during surgery for tumors larger than 1.5 cm compared to conventional wire-guided localization (WGL), while maintaining similar rates of negative margins.

BWL is also a viable alternative to intraoperative ultrasound guidance for poorly defined breast tumors, achieving better resection ratios than ultrasound in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of Wire-guided Technique With Bracketing Reduces Resection Volumes in Breast-conserving Surgery for Early Breast Cancer. Civil, YA., Duvivier, KM., Perin, P., et al.[2021]

Electromagnetic seed localization (ESL) for breast-conserving surgery resulted in significantly smaller specimen volumes compared to wire localization (WL), indicating a more precise removal of tissue (36 cm³ vs. 55 cm³).

While the differences in positive margins and re-excision rates between ESL and WL were not statistically significant, ESL showed a trend towards fewer positive margins (10% vs. 19%) and lower re-excision rates (6% vs. 13%), suggesting it may be a safer option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of an Electromagnetic Seed Localization Device Versus Wire Localization on Breast-Conserving Surgery: A Matched-Pair Analysis. Jordan, RM., Rivera-Sanchez, L., Kelley, K., et al.[2023]

In a study of 143 patients with nonpalpable breast lesions, the use of hydrogel clips allowed 71.3% of patients to avoid preoperative wire localization (WL), utilizing intraoperative ultrasonography instead.

The positive margin rate was similar between patients who underwent WL and those who did not (5.9% vs 11.5%), indicating that using hydrogel clips is a safe and effective alternative to WL for breast lumpectomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Implementation of Intraoperative Ultrasonography to Reduce Wire Localization in The Permanente Medical Group. Chang, S., Brooke, M., Cureton, E., et al.[2020]

Radioactive seed localization (RSL) significantly reduced the need for specimen radiographs in 79% of patients, demonstrating its effectiveness in streamlining the surgical process for nonpalpable breast lesions.

RSL achieved a 100% success rate in surgical seed retrieval without any seed migration, indicating its reliability and potential to improve surgical outcomes by reducing operating room delays and enhancing incision placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioactive seed localization breast biopsy and lumpectomy: can specimen radiographs be eliminated? Cox, CE., Furman, B., Stowell, N., et al.[2019]

The Breast Cancer Locator™ (BCL) system, which uses supine MRI images to guide tumor localization, was successfully implemented by multiple surgeons across four sites, demonstrating its feasibility and safety.

In a study involving 14 patients, the BCL system achieved a 92% success rate in placing the central localization wire within the tumor, and all excised tumors had negative margins, indicating effective cancer removal without adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot multi-institutional study to evaluate the accuracy of a supine MRI based guidance system, the Breast Cancer Locator™, in patients with palpable breast cancer. Barth, RJ., Krishnaswamy, V., Rooney, TB., et al.[2022]

References

1. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Oncoplastic breast conserving surgery with tailored needle-guided excision. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Optimization of Wire-guided Technique With Bracketing Reduces Resection Volumes in Breast-conserving Surgery for Early Breast Cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The Impact of an Electromagnetic Seed Localization Device Versus Wire Localization on Breast-Conserving Surgery: A Matched-Pair Analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Rapid Implementation of Intraoperative Ultrasonography to Reduce Wire Localization in The Permanente Medical Group. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Radioactive seed localization breast biopsy and lumpectomy: can specimen radiographs be eliminated? [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A pilot multi-institutional study to evaluate the accuracy of a supine MRI based guidance system, the Breast Cancer Locator™, in patients with palpable breast cancer. [2022]