CairnSurgical Breast Cancer Locator (BCL) Post-Market Study

NCT06461663 | Completed FDA Device

• 1 other identifier: CS-BCL-EU2021
• Study Type: interventional
• Target: 35
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 will be obtained.

  Pathology results will from the index procedure be available within 14 days from the day of sample arrival at the pathological lab.

Secondary Outcomes (4)

• Specimen volume

  Results will be obtained the same day of surgery.

• Surgeon's Perception

  Results will be obtained prior to subject discharge after the study procedure (within approximately 2 days after surgery)

• Adverse events

  From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery

• Patient Satisfaction

  6 weeks +/- 7 days post surgery

Study Arms (1)

Treatment with BCL

EXPERIMENTAL

Subjects will undergo breast conserving surgery with the Breast Cancer Locator (BCL)

Device: Breast Cancer Locator Guided Breast Conserving Surgery

Interventions

Breast Cancer Locator Guided Breast Conserving Surgery DEVICE

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.

Treatment with BCL

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Known drug and/or alcohol abuse

Sponsors & Collaborators

• CairnSurgical, Inc.: lead

Study Sites (5)

Agaplesion Markus Hospital

Frankfurt, 60431, Germany

Location

Universitats Klinikum Heidelberg

Heidelberg, Germany

Location

Humanitas Research Hospital

Milan, Italy

Location

Ospdale Santa Chiara

Pisa, Italy

Location

Spital Zollikerberg

Zurich, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Richard Barth, MD

  Cairn Surgical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will undergo breast conserving surgery with the BCL.

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: June 17, 2024
• Study Start: July 22, 2022
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); IT (2); DE (2)