Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer

February 20, 2024 updated by: CairnSurgical, Inc.

Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

The BCL System is intended to be used to guide a surgeon when performing partial mastectomy for breast cancer and to minimize positive margins. 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 invasive breast cancer and DCIS.

Investigators in the intervention group will be provided with a three dimensional (3D) image of the cancer in the breast which allows them to visualize the closest distance from the tumor to the skin and the chest wall and quantifies those distances. Investigators will also use a BCL, which is a patient specific, plastic, bra-like form that is transiently placed on the breast prior to surgery and allows the Investigator to mark the projected edges of the tumor on the breast skin and to place bracketing wires inside the breast which define the center of the cancer and distances 1 cm from the tumor edges defined by pre-operative supine MRI.

Study Type

Interventional

Enrollment (Estimated)

448

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
  • United Kingdom
      • London, United Kingdom
        • Royal Free London NHS Trust
      • Manchester, United Kingdom
        • Manchester University NHS
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Arizona Center for Cancer Care
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist MD Anderson Cancer Center
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Danvers, Massachusetts, United States, 01923
        • Mass General/North Shore Center for Outpatient Care
      • Easton, Massachusetts, United States, 02356
        • Steward Medical Group
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin Healthcare
    • New Hampshire
      • Keene, New Hampshire, United States, 03431
        • Cheshire Medical Center
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Medical Center
      • Manchester, New Hampshire, United States, 03102
        • Catholic Medical Center
      • Nashua, New Hampshire, United States, 03060
        • St. Joseph Hospital
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Summit Health
    • New York
      • Albany, New York, United States, 12208
        • St. Peter's Hospital
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center and New York-Presbyterian Hospital
    • Ohio
      • Columbus, Ohio, United States, 43212
        • The Ohio State University Comprehensive Cancer Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
      • Warwick, Rhode Island, United States, 02886
        • Kent Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Vermont
      • Rutland, Vermont, United States, 05701
        • Rutland Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female gender
  • Age > 18 years
  • Histologic diagnosis of invasive breast cancer or DCIS
  • The surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation
  • The tumor is unifocal; possible satellite lesions < or = 2 cm from primary are eligible
  • The tumor enhances on prone breast MRI imaging
  • The tumor is ≥ 1 cm in diameter on mammography or prone MRI
  • Subject and surgeon agree to perform BCS
  • Ability to voluntarily provide informed consent

Exclusion Criteria:

  • Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes
  • Severe claustrophobia
  • Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy
  • Compromised renal function including chronic, severe kidney disease (GFR < 30 ml/min/1.73m2), or acute kidney injury
  • Pregnancy - In women of childbearing age a urine pregnancy test will be performed
  • Subjects who have received or plan to receive neoadjuvant chemotherapy
  • Sternal notch to nipple distance of > 32 cm as measured in a sitting or standing position
  • Measurement of widest circumference around breasts and arms > 135 cm
  • Subjects with known allergy to materials present in the device
  • Use of localization with devices other than a localization wire, including intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices (MarginProbe)
  • Subject would require > 2 localization wires, if randomized to standard of care
  • Multicentric tumors (additional tumors > 2 cm from primary)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breast Cancer Locator (BCL)
Subject randomized to BCL surgical guidance to perform partial mastectomy
Device: Breast Cancer Locator (BCL) guided partial mastectomy
The BCL is a patient-specific, plastic, bra-like form which is placed on the breast to localize the tumor during surgery.
Active Comparator: Wire Localization (WL)
Subject randomized to WL surgical guidance to perform partial mastectomy
Device: Wire Localized (WL) partial mastectomy
Standard of care procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive margin rate
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To provide evidence that the positive margin rate following BCS using the BCL is not inferior to the standard of care (WL) for surgical guidance
At completion of study recruitment, approximately 18 months after first subject enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specimen volumes
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare specimen volumes for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled
Re-excision rate
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare re-excision rate for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled
Cancer localization rate
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare cancer localization rate for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled
Operative times
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare operative times for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled
Adverse event rate
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare adverse event rate for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled
Rate of additional shave biopsies
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare rate of additional shave biopsies for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled
Costs of care
Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To compare costs of care for women randomized to BCL vs. WL-guided BCS
At completion of study recruitment, approximately 18 months after first subject enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CairnSurgical, Inc.

Investigators

  • Principal Investigator: Jennifer Gass, MD, Women & Infants Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2020

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCL IDE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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