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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 belowSelect...
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 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
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility 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.My surgeon needs special techniques to locate my tumor because it can't be felt by hand.I need more than 2 wires to locate my tumor if I receive standard treatment.The tumor shows up more clearly on a special type of breast MRI scan.You have severe fear of small, enclosed spaces.My tumor is at least 1 cm big as shown on a scan.I am older than 18 years.I have been diagnosed with invasive breast cancer or DCIS.I am using or have used advanced localization methods for my surgery, not including wires.I am female.Your chest and arm circumference is larger than 135 cm.I have more than one tumor, and they are spread out.I have received or will receive chemotherapy before surgery.The distance from the top of your breastbone to your nipple is more than 32 centimeters when measured while sitting or standing.My surgeon and I agree to perform breast-conserving surgery.My kidney function is severely reduced.My tumor is single and may have small nearby spots.
Research Study Groups:
This trial has the following groups:- Group 1: Breast Cancer Locator (BCL)
- Group 2: Wire Localization (WL)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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