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

• ClinicalTrials.gov Identifier: NCT04397185
• Recruitment Status: Suspended
• First Posted: May 21, 2020
• Last Update Posted: February 21, 2024
• Sponsor: CairnSurgical, Inc.
• Information provided by (Responsible Party): CairnSurgical, Inc.

Tracking Information

• First Submitted Date: May 15, 2020
• First Posted Date: May 21, 2020
• Last Update Posted Date: February 21, 2024
• Actual Study Start Date: December 23, 2020
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 19, 2020)

Positive margin rate [ Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled ]

To provide evidence that the positive margin rate following BCS using the BCL is not inferior to the standard of care (WL) for surgical guidance

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 19, 2020)

• Specimen volumes [ Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled ]
  To compare specimen volumes for women randomized to BCL vs. WL-guided BCS
• Re-excision rate [ Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled ]
  To compare re-excision rate for women randomized to BCL vs. WL-guided BCS
• Cancer localization rate [ Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled ]
  To compare cancer localization rate for women randomized to BCL vs. WL-guided BCS
• Operative times [ Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled ]
  To compare operative times for women randomized to BCL vs. WL-guided BCS
• Adverse event rate [ Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled ]
  To compare adverse event rate for women randomized to BCL vs. WL-guided BCS
• Rate of additional shave biopsies [ Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled ]
  To compare rate of additional shave biopsies for women randomized to BCL vs. WL-guided BCS
• Costs of care [ Time Frame: At completion of study recruitment, approximately 18 months after first subject enrolled ]
  To compare costs of care for women randomized to BCL vs. WL-guided BCS

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
• Official Title: Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
• Brief Summary: 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.

Detailed Description

The BCL System is intended to be used to guide a surgeon when performing partial mastectomy for breast cancer and to minimize positive margins. The purpose of this study is to provide evidence that the BCL is safe, effective, and non-inferior to the standard of care (WL) in the removal of non-palpable invasive breast cancer and DCIS.

Investigators in the intervention group will be provided with a three dimensional (3D) image of the cancer in the breast which allows them to visualize the closest distance from the tumor to the skin and the chest wall and quantifies those distances. Investigators will also use a BCL, which is a patient specific, plastic, bra-like form that is transiently placed on the breast prior to surgery and allows the Investigator to mark the projected edges of the tumor on the breast skin and to place bracketing wires inside the breast which define the center of the cancer and distances 1 cm from the tumor edges defined by pre-operative supine MRI.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

Pathologist will be blinded to the study assignment (BCL vs. WL)

Primary Purpose: Treatment

• Condition: Breast Cancer Female

Intervention

• Device: Breast Cancer Locator (BCL) guided partial mastectomy
  The BCL is a patient-specific, plastic, bra-like form which is placed on the breast to localize the tumor during surgery.
• Device: Wire Localized (WL) partial mastectomy
  Standard of care procedure

Study Arms

• Experimental: Breast Cancer Locator (BCL)
  Subject randomized to BCL surgical guidance to perform partial mastectomy
  Intervention: Device: Breast Cancer Locator (BCL) guided partial mastectomy
• Active Comparator: Wire Localization (WL)
  Subject randomized to WL surgical guidance to perform partial mastectomy
  Intervention: Device: Wire Localized (WL) partial mastectomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: May 19, 2020): 448
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2024
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion 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; possible satellite lesions < or = 2 cm from primary are eligible
• The tumor enhances on prone breast MRI imaging
• The tumor is ≥ 1 cm in diameter on mammography or prone MRI
• Subject and surgeon agree to perform BCS
• Ability to voluntarily provide informed consent

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
• Compromised renal function including chronic, severe kidney disease (GFR < 30 ml/min/1.73m2), or acute kidney injury
• Pregnancy - In women of childbearing age 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
• 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
• Multicentric tumors (additional tumors > 2 cm from primary)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United Kingdom, United States

Administrative Information

• NCT Number: NCT04397185
• Other Study ID Numbers: BCL IDE
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: CairnSurgical, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: CairnSurgical, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jennifer Gass, MD; Women & Infants Hospital

• PRS Account: CairnSurgical, Inc.
• Verification Date: February 2024