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



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:6/23/2018
Start Date:August 2015
End Date:February 2018

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

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

The investigators propose to test whether the Breast Cancer Locator (BCL) accurately defines
the edges of the cancer. Twenty patients with palpable invasive breast cancer will undergo
preoperative supine MRI, 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.

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.
We found this trial at
1
site
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Phone: 800-639-6918
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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