CairnSurgical Breast Cancer Locator (BCL) Post-Market Study

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)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Breast Cancer Locator Guided Breast Conserving Surgery

Detailed Description

The aim of this interventional, post-market, multicenter clinical investigation is to evaluate the performance of a custom-made medical device, the Breast Cancer Locator (BCL) system, in subjects with non-palpable breast cancer. The study will be conducted in European countries. To evaluate the performance of BCL in reducing the positive margin rate, the proportion of patients with positive margins after partial mastectomy with the BCL will be obtained.

Each Subject, after signing an Informed Consent Form (ICF), will enter into a screening phase, during which several assessments (e.g., demographics, medical history, evaluation of available prone MRI and core biopsy pathological results) will be conducted.

At visit 1, the Subject will undergo supine MRI, from which a 3D breast image and BCL will be made.

At visit 2, the patient will undergo Breast Conserving Surgery (BCS) using the BCL system. On the same day, the specimen volume will be determined. The excised specimen will be sent to the pathological lab for analysis. The results, including the positive margin rate (PMR) and specimen mammogram, will be obtained within 14 days.

At visit 3, follow-up assessments (including physical examination, and adverse event review) will be performed.

At the End Of Study visit, adverse events will be assessed and patients will be asked to express their satisfaction with the BREAST-Q.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Frankfurt, Germany
    • Agaplesion Markus Krankenhaus
  • Heidelberg, Germany
    • Breast Unit Heidelberg, St Elisabeth Hospital
• Italy
  • Milan, Italy
    • U.O. Senologia, Instituto Clinico Humanitas
  • Pisa, Italy
    • U.O. Senologia Ospedale Santa Chiara, Azienda Ospedaliera Universitaria Pisana
• Switzerland
  • Bellinzona, Switzerland
    • Ospedale Regionale di Bellinzona e Valli
  • Zurich, Switzerland
    • Spital Zollikerberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment with BCL; Subjects will undergo breast conserving surgery with the Breast Cancer Locator (BCL)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Margin Rate	To evaluate the performance of BCL in reducing the positive margin rate, the proportion of patients with positive margins after partial mastectomy with the BCL was obtained.	Pathology results from the index procedure available within 14 days from the day of sample arrival at the pathological lab.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon's Perception	To evaluate the surgeon's perception of the BCL system, a survey asking them if they strongly disagree, somewhat disagree, are undecided, somewhat agree, or strongly agree that the BCL made tumor localization easier, was easy to use, made tumor excision easier, and would be recommended by them, will be used.	Results will be obtained prior to subject discharge after the study procedure (within approximately 2 days after surgery)
Specimen Volume	To calculate the specimen volume after BCL guided partial mastectomy, the water displacement method (WDM) was used.	Results obtained the same day of surgery.
Number of Participants With Adverse Events	To evaluate the safety and tolerability of BCL, adverse events will be reported, including frequency, maximum intensity, relation to study treatment, seriousness, action taken, and outcome. Safety data will be handled descriptively.	From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery
Patient Satisfaction	To evaluate the patient's satisfaction, the BREAST-Q patient-reported outcome measure will be used. Patient satisfaction scores range from 0-100, with a higher score meaning greater satisfaction or better quality of life.	6 weeks +/- 7 days post surgery

Collaborators and Investigators

• Sponsor: CairnSurgical, Inc.
• Investigators: Study Director: Richard J Barth, MD, Cairn Surgical

Publications and helpful links

General Publications

• Thill M, Ghilli M, Roncella M, Kelling K, Fansa H, Golatta M, Heil J, Haasteren V, Freitag A, Togawa R, Sagona A, Rooney TB, Fox MJ, Barth RJ Jr. A Multi-institutional Study to Evaluate the Effectiveness and Safety of a Supine MRI-Based Guidance System, the Breast Cancer LocatorTM, for Breast Conserving Surgery in Patients with Nonpalpable Breast Cancer. Ann Surg Oncol. 2025 Jun 6. doi: 10.1245/s10434-025-17513-4. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Actual): April 19, 2024
• Study Completion (Actual): April 19, 2024

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: CS-BCL-EU2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes