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Clinical Trial 20631

Cancer Type: Breast
Study Type: Device Feasibility
NCT#: NCT04397185

Phase: N/A
Prinicipal Investigator: Nazanin Khakpour

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Overview

Study Title

Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer

Summary

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.

Objective

Primary objective: 1. 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 Objectives: 1. To compare the specimen volumes for women randomized to BCL or WL guided BCS. 2. To compare the re-excision rate for women randomized to BCL or WL guided BCS. 3. To compare the cancer localization rate for women randomized to BCL or WL guided BCS. 4. To compare the operative times for women randomized to BCL or WL guided BCS.

Treatments

Therapies

Medications

Not Applicable ()

Inclusion Criteria

Inclusion Criteria:

  • Female gender
  • Age 18 years and older
  • Histologic diagnosis of invasive breast cancer or DCIS
  • The tumor cannot be definitively detected by palpation
  • The tumor is unifocal; possible satellite lesions > The tumor enhances on prone breast MRI imaging
  • The tumor is visible on mammography
  • The tumor is less than or equal to 1 cm in diameter on mammography or prone MRI
  • Subject and surgeon agree to perform BCS
  • Ability to voluntarily provide informed consent

  • Exclusion Criteria

    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 > 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)

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