A Study to Evaluate the Accuracy of a Breast Cancer Locator (BCL) in Patients With Palpable Cancers

Dartmouth Health

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Breast Cancer Locator (BCL)

Study type: Interventional

Funder types: Other

Identifiers

NCT02550210

D15120

Details and patient eligibility

About

In this study, the investigators will enroll women with palpable cancers to assess the accuracy of the Breast Cancer Locator (BCL) and the concomitant procedure as a vehicle to optimize and validate the approach in such surgical cases. This approach of adopting palpable cancer patients before initiating an evaluative trial of the BCL in non-palpable breast cancer cases ensures that the BCL does not substantially alter or modify the standard-of-care procedure.

Full description

The investigators propose to test whether the Breast Cancer Locator (BCL) accurately defines the edges of the tumor. Twenty patients with palpable invasive breast cancer will undergo preoperative supine MRI, the creation of a BCL, and breast-conserving surgery using the BCL as an adjunct to palpation-guided tumor resection. Participants will also have the tumor position on their skin localized with the supine MR/optical scan/tracker method. The primary objective is to measure the distance from the center of the spots made by the BCL to the cancer edges.

Enrollment: 23 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than or equal to 18 years
• Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ
• Patient desire to undergo breast surgery
• Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted
• The cancer enhances on breast MRI imaging.

Exclusion criteria

• Absolute contraindication to MRI, including presence of implanted electrical device (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 or compromised renal function (creatinine > 2.0)
• History of median sternotomy
• Pregnancy. Patient attestation that they are not pregnant will be acceptable as per standard policy for MRIs at DHMC.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Breast Cancer Locator (BCL)

Experimental group

Description:

The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure.

Treatment:

Device: Breast Cancer Locator (BCL)