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

Not Applicable

Completed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Breast Cancer Locator (BCL)	Breast Cancer Locator (BCL)	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.

Primary Outcome Measures

Name	Time	Method
The Distance Measured by Pathology From the Tumor Edge to the Center of the Ink Spots, as Marked by the Black Inked Pins.	30 Days	Five measurements will be made per patient and the mean difference in distance will be derived between the palpated and the co-registered supine MRI-optical scan image predicted tumor edges. The BCL will be considered accurate if all 5 measurements are \> 0 cm from the tumor edge.

Secondary Outcome Measures

Name	Time	Method
Positive Margin Rate	30 Days	The positive margin rate as defined by standard pathologic evaluation of the entire specimen.
The Distances Between the Specimen Edges as Determined by the Breast Cancer Locator and by the Supine MRI/Optical Scan/ Tracker System	30 days	Distances will be measured and descriptive statistics will be employed.
Mean Resection Specimen Volume	30 days from surgery	Volumes will be measured and descriptive statistics will be employed. The specimen volume is determined by recording the water displacement and specimen scanning.