COMPLETED

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2020-12-23

Study Completion:2025-12-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04397185

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Jennifer Gass, MD

PRINCIPAL_INVESTIGATOR

Women & Infants Hospital

Study Locations (Sites)

Arizona Center for Cancer Care

Scottsdale, Arizona, 85258

United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Tufts Medical Center

Boston, Massachusetts, 02111

United States

Mass General/North Shore Center for Outpatient Care

Danvers, Massachusetts, 01923

United States

Steward Medical Group

Easton, Massachusetts, 02356

United States

Hennepin Healthcare

Minneapolis, Minnesota, 55415

United States

Cheshire Medical Center

Keene, New Hampshire, 03431

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766

United States

Catholic Medical Center

Manchester, New Hampshire, 03102

United States

St. Joseph Hospital

Nashua, New Hampshire, 03060

United States

Summit Health

Florham Park, New Jersey, 07932

United States

St. Peter's Hospital

Albany, New York, 12208

United States

Columbia University Irving Medical Center and New York-Presbyterian Hospital

New York, New York, 10032

United States

Women and Infants Hospital

Providence, Rhode Island, 02905

United States

Kent Hospital

Warwick, Rhode Island, 02886

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Rutland Regional Medical Center

Rutland, Vermont, 05701

United States

Inova Schar Cancer Institute

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: CairnSurgical, Inc.

Jennifer Gass, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2020-12-23

Study Completion Date2025-12-09

Study Record Updates

Study Start Date2020-12-23

Study Completion Date2025-12-09

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer Female