BCL vs WL Guided Surgery for Breast Cancer

Recruiting in Palo Alto (17 mi)

+19 other locations

Overseen by Jennifer Gass, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: CairnSurgical, Inc.

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

No Placebo Group

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}

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.

Trial 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

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Columbia Medical Center New York, NY

BASS Medical Group Walnut Creek, CA

Dartmouth-Hitchcock Medical Center Lebanon, NH

Princess Margaret Cancer Centre Toronto, Canada

More Trial Locations

Who Is Running the Clinical Trial?

CairnSurgical, Inc. Lead Sponsor

References

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

Oncoplastic breast conserving surgery with tailored needle-guided excision. [2022] Breast conserving surgery (BCS) administered with oncoplastic approach (OBCS), when it is required, is currently the gold standard for the treatment of early breast cancer. Wire-guided localization (WL) is the most popular technique used to help surgeon in breast cancer excision. Currently, a universal and undeniable goal is to minimize the rate of positive margins and re-excision operation after BCS improving cosmetic outcome and decreasing health care costs. This study is aimed to report our experience combining OBCS and tailored WL as surgical approach for early breast cancers.

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] Wire-guided localization (WGL) of early breast cancer can be facilitated using multiple wires, which is called bracketing wire-guided localization (BWL). The primary aim of this study is to compare BWL and conventional WGL regarding minimization of resection volumes without compromising margin status. Secondly, BWL is evaluated as an alternative method for intraoperative ultrasound (US) guidance in poorly definable breast tumors on US.

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] For breast-conserving surgery (BCS), several alternatives to wire localization (WL) have been developed. The newest, electromagnetic seed localization (ESL), provides three-dimensional navigation using the electrosurgical tool. This study assessed operative times, specimen volumes, margin positivity, and re-excision rates for ESL and WL.

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

Rapid Implementation of Intraoperative Ultrasonography to Reduce Wire Localization in The Permanente Medical Group. [2020] Preoperative wire localization (WL), the most common localization technique for nonpalpable breast lesions, has drawbacks including scheduling constraints, cost, and patient discomfort.

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

Radioactive seed localization breast biopsy and lumpectomy: can specimen radiographs be eliminated? [2019] Wire localization (WL) is the current standard for surgical diagnosis of nonpalpable breast lesions. Many disadvantages inherent to WL are solved with radioactive seed localization (RSL). This trial investigated the ability of RSL to reduce the need for specimen radiographs and operating room delays associated with WL.

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] Evaluate whether the Breast Cancer Locator™ (BCL), a novel guidance system based on supine MRI images, can be safely and effectively deployed by several surgeons at multiple sites.