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Procedure

BCL vs WL Guided Surgery for Breast Cancer

N/A
Waitlist Available
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 surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation
The tumor is ≥ 1 cm in diameter on mammography or prone MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at completion of study recruitment, approximately 18 months after first subject enrolled
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 surgeon needs special techniques to locate my tumor because it can't be felt by hand.
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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.
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My surgeon and I agree to perform breast-conserving surgery.
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My tumor is single and may have small nearby spots.

Timeline

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Positive margin rate
Secondary outcome measures
Adverse event rate
Cancer localization rate
Costs of care
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Breast Cancer Locator (BCL)Experimental Treatment1 Intervention
Subject randomized to BCL surgical guidance to perform partial mastectomy
Group II: Wire Localization (WL)Active Control1 Intervention
Subject randomized to WL surgical guidance to perform partial mastectomy

Find a Location

Who is running the clinical trial?

CairnSurgical, Inc.Lead Sponsor
1 Previous Clinical Trials
45 Total Patients Enrolled
Jennifer Gass, MDPrincipal InvestigatorWomen & Infants Hospital

Media Library

Breast Cancer Locator (BCL) guided partial mastectomy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04397185 — N/A
Breast Cancer Research Study Groups: Breast Cancer Locator (BCL), Wire Localization (WL)
Breast Cancer Clinical Trial 2023: Breast Cancer Locator (BCL) guided partial mastectomy Highlights & Side Effects. Trial Name: NCT04397185 — N/A
Breast Cancer Locator (BCL) guided partial mastectomy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04397185 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~32 spots leftby Jul 2024