CairnSurgical Breast Cancer Locator (BCL) Post-Market Study

Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06461663
• Other study ID #: CS-BCL-EU2021
• Status: Completed
• Phase: N/A
• Start date: July 22, 2022
• Est. completion date: April 19, 2024

Study information

• Verified date: June 2024
• Source: CairnSurgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 19, 2024
• Est. primary completion date: April 19, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Germany	Agaplesion Markus Hospital	Frankfurt
Germany	Universitats Klinikum Heidelberg	Heidelberg
Italy	Humanitas Research Hospital	Milan
Italy	Ospdale Santa Chiara	Pisa
Switzerland	Spital Zollikerberg	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
CairnSurgical, Inc.

Countries where clinical trial is conducted

Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Specimen volume	To calculate the specimen volume after BCL guided partial mastectomy, the water displacement method (WDM) will be used.	Results will be obtained the same day of surgery.
Secondary	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)
Secondary	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
Secondary	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 (depending on the scale).	6 weeks +/- 7 days post surgery