BCL vs WL Guided Surgery for Breast Cancer

Not currently recruiting at 25 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods to guide surgery for women with certain types of breast cancer that can't be felt by touch. It compares the Breast Cancer Locator (BCL), a newer method, with the traditional wire localization (WL) method to determine which is safer and more effective during partial breast removal surgery. Women with breast cancer requiring pre-op mapping due to non-palpable tumors may be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

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 prior data suggests that the Breast Cancer Locator (BCL) is safe for guiding surgery?

Previous studies have shown the Breast Cancer Locator (BCL) to be safe, with no serious side effects reported. The safety results matched those of typical breast-conserving surgeries. Notably, 91% of surgeons expressed satisfaction with the BCL system. This suggests that the BCL is easy to use and performs as well as traditional methods like wire localization (WL) for guiding breast cancer surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing the Breast Cancer Locator (BCL) guided surgery with the traditional Wire Localized (WL) approach for breast cancer surgery because BCL offers a more precise and less invasive way to locate and remove tumors. Unlike the WL method, which involves placing a wire to guide surgeons, BCL uses advanced imaging to pinpoint the tumor's exact location. This could potentially lead to quicker surgeries, less discomfort for patients, and better cosmetic outcomes, which are significant improvements over the current standard of care.

What evidence suggests that this trial's surgical guidance methods could be effective for breast cancer?

This trial will compare the Breast Cancer Locator (BCL) guided partial mastectomy with the Wire Localized (WL) partial mastectomy. Research has shown that the BCL is a promising tool for breast-conserving surgery. One study found that the BCL successfully guided the placement of a wire in the center of the tumor in 92% of patients. This high accuracy can lead to more precise surgeries, potentially improving outcomes for patients with non-palpable breast cancer or ductal carcinoma in situ (DCIS). The BCL also aims to match the safety and effectiveness of the standard wire localization method. Overall, early findings suggest that BCL could reliably guide breast cancer surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Jennifer Gass, MD

Principal Investigator

Women & Infants Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04397185

Breast Cancer Locator Guided vs. Wire Localized Partial ... The purpose of this study is to provide evidence that the BCL is safe, effective, and non-inferior to the standard of care (WL) in the removal of non-palpable ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40478342/

A Multi-institutional Study to Evaluate the Effectiveness and ... The Breast Cancer Locator TM (BCL) has been demonstrated to be a safe and effective guidance system for breast-conserving surgery (BCS) in patients with ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0960740422001384

A pilot multi-institutional study to evaluate the accuracy of ... Using this guidance system, cancers in all study patients were successfully bracketed and 92% had a central wire placed into the tumor on specimen mammogram.

4. withpower.com withpower.com/trial/phase-breast-neoplasms-11-2020-83bdf

BCL vs WL Guided Surgery for Breast Cancer 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 ...

5. cancer.dartmouth.edu cancer.dartmouth.edu/patients-families/find-clinical-trial/trial/F20073

Randomized Prospective Trial of Breast Cancer Locator ... This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in ...

6. biospace.com biospace.com/press-releases/new-published-data-shows-breast-cancer-locator-system-dramatically-improves-surgeon-ability-to-remove-entire-tumor-with-negative-margins

New Published Data Shows Breast Cancer Locator System ... No serious adverse events were observed; safety outcomes were comparable to typical breast conserving surgery; 91% of surgeons were satisfied ...