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

Description

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.

Conditions

Breast Cancer Female

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Breast Cancer Female
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Arizona Center for Cancer Care, Scottsdale, Arizona, United States, 85258

Walnut Creek

BASS Medical Group, Walnut Creek, California, United States, 94598

Jacksonville

Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States, 32207

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Boston

Tufts Medical Center, Boston, Massachusetts, United States, 02111

Danvers

Mass General/North Shore Center for Outpatient Care, Danvers, Massachusetts, United States, 01923

Easton

Steward Medical Group, Easton, Massachusetts, United States, 02356

Minneapolis

Hennepin Healthcare, Minneapolis, Minnesota, United States, 55415

Keene

Cheshire Medical Center, Keene, New Hampshire, United States, 03431

Lebanon

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States, 03766

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 or multifocal with satellite lesions \< or = 2 cm from primary tumor
  • * The tumor enhances on prone breast MRI imaging
  • * The tumor is ≥ 1 cm in diameter on prone breast MRI
  • * Subject and surgeon agree to perform BCS
  • * Subject voluntarily provides informed consent
  • * 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 that precludes prone or supine MRI
  • * 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 potential, 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 for sites using 60cm bore scanners, and measurement of widest circumference around breasts and arms \>145 cm for sites using 70 cm bore scanners
  • * 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
  • * Subjects with multicentric tumors (additional tumors \> 2 cm from primary)
  • * Subject would require chest wall muscle nerve block as part of the operation

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

CairnSurgical, Inc.,

Jennifer Gass, MD, PRINCIPAL_INVESTIGATOR, Women & Infants Hospital

Study Record Dates

2025-04