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NCT06461663

CairnSurgical Breast Cancer Locator (BCL) Post-Market Study

Sponsor: CairnSurgical, Inc.

View on ClinicalTrials.gov

Summary

This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in Europe.

Official title: An Interventional, Post-Market Study to Evaluate the Performance of a Custom-made Medical Device, "Breast Cancer Locator (BCL)" System, in Breast-conserving Surgery (BCS)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-06-22

Completion Date

2024-04-19

Last Updated

2026-05-27

Healthy Volunteers

Conditions

Breast Cancer

Interventions

DEVICE

Breast Cancer Locator Guided Breast Conserving Surgery

Subjects will undergo a contrast-enhanced supine MRI and two marks will be placed on the breast. The MRI images will be transmitted to the sponsor, and the images will be used to build a BCL using 3D printing. Investigators will be provided with a 3D image of the cancer in the breast. Investigators will use a BCL (a patient-specific, plastic, bra-like form that is placed on the breast and allows the investigator to mark the edges of the tumor on the skin and to place wires inside the breast which define the center of the cancer and the tumor edges. The surgeon will then attempt to surgically remove all the tissue inside the wires used to define the tumor edges.

Inclusion Criteria: * Patient Informed consent form (ICF) signed * Female Aged ≥ 18 years at the time of the signature of ICF * Histologic diagnosis of IBC or DCIS * Tumor excision that will require localization because it cannot be definitively defined by palpation * The tumor is unifocal; possible satellite lesions \< 2 cm from primary are eligible * The tumor enhances and is greater than or equal to 5mm on prone breast MRI imaging * Subject and surgeon agree to perform BCS * Willingness to follow all study procedures, including attending all site visits, tests and examinations. 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 * Uncontrolled cardiac, renal, or pulmonary disease * Uncontrolled systemic disease (e.g., lupus erythematosus or scleroderma) * Compromised renal function including chronic, severe kidney disease (GFR \< 30 ml/min/1.73m2), or acute kidney injury * Pregnancy or breast-feeding * 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 * Known allergy to device components * Multicentric tumors (additional tumors \> 2 cm from primary) * Infectious or inflammatory processes near the area of intervention * Planned surgery with localization devices including WGL, intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices * Simultaneous participation in an interventional study or participation in an interventional study in the last 1 month before study inclusion * Known drug and/or alcohol abuse * Mental incapacity that precludes adequate understanding or cooperation

Locations (6)

Agaplesion Markus Krankenhaus

Frankfurt, Germany

Breast Unit Heidelberg, St Elisabeth Hospital

Heidelberg, Germany

U.O. Senologia, Instituto Clinico Humanitas

Milan, Italy

U.O. Senologia Ospedale Santa Chiara, Azienda Ospedaliera Universitaria Pisana

Pisa, Italy

Ospedale Regionale di Bellinzona e Valli

Bellinzona, Switzerland

Spital Zollikerberg

Zurich, Switzerland