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

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ClinicalTrials.gov Identifier: NCT04397185
Recruitment Status : Suspended (Enrollment temporarily paused while sponsor responds to questions from FDA.)
First Posted : May 21, 2020
Last Update Posted : February 21, 2024
Sponsor:
Information provided by (Responsible Party):
CairnSurgical, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Device: Breast Cancer Locator (BCL) guided partial mastectomy Device: Wire Localized (WL) partial mastectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 448 participants
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
Official Title: Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
Actual Study Start Date : December 23, 2020
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Breast Cancer Locator (BCL)
Subject randomized to BCL surgical guidance to perform partial mastectomy
 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.
Active Comparator: Wire Localization (WL)
Subject randomized to WL surgical guidance to perform partial mastectomy
 Device: Wire Localized (WL) partial mastectomy
Standard of care procedure


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397185


Locations
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Sponsors and Collaborators
CairnSurgical, Inc.
Investigators
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Principal Investigator: Jennifer Gass, MD Women & Infants Hospital
More Information
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Responsible Party: CairnSurgical, Inc.
ClinicalTrials.gov Identifier: NCT04397185    
Other Study ID Numbers: BCL IDE
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: February 21, 2024
Last Verified: February 2024

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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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases