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Procedure

BCL vs WL Guided Surgery for Breast Cancer

N/A

Recruiting

Led By Jennifer Gass, MD

Research Sponsored by CairnSurgical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The tumor is ≥ 1 cm in diameter on mammography or prone MRI

Age > 18 years

Must not have

Contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy

Subject would require > 2 localization wires, if randomized to standard of care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at completion of study recruitment, approximately 18 months after first subject enrolled

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to compare the safety and effectiveness of two methods for guiding breast cancer surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not detailed here, surgical procedures may include risks such as infection, bleeding, pain at the incision site, changes in breast sensation or shape, and reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is at least 1 cm big as shown on a scan.

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I am older than 18 years.

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I have been diagnosed with invasive breast cancer or DCIS.

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I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am severely allergic to gadolinium-based contrast.

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

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I am using or have used advanced localization methods for my surgery, not including wires.

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I have more than one tumor, and they are spread out.

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I have received or will receive chemotherapy before surgery.

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My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at completion of study recruitment, approximately 18 months after first subject enrolled

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at completion of study recruitment, approximately 18 months after first subject enrolled

This trial's timeline: 3 weeks for screening, Varies for treatment, and at completion of study recruitment, approximately 18 months after first subject enrolled for reporting.