A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers

NCT ID: NCT03573661

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-24
• Study Completion Date: 2021-04-05

Brief Summary

The project objective is to determine whether the Breast Cancer Locator (BCL) can safely and effectively localize breast cancers in patients treated at locations distant from the site of BCL manufacture. This information will be transmitted to CairnSurgical, Inc. where the BCL will be fabricated, tested for quality assurance, sterilized and shipped to the patient's surgeon. The surgeon will then utilize the BCL at the time of resection of the palpable breast cancer.

Detailed Description

The primary purpose of the study is to determine whether a device called the Breast Cancer Locator (BCL) accurately identifies the location of cancer in the breast. The Breast Cancer Locator is a plastic bra-like form that gives the surgeon information about the location of the cancer in the breast. The location information is derived from an MRI which is obtained with the patient lying flat on their back (just as they are on an operating room table). The BCL is then custom-made for the patient using 3D printing technology.

The surgeon can feel the cancer, and the surgeon will remove the cancer by feeling the edges of it as the surgeon would normally. Since the cancer can be felt, the surgeon does not need an image guidance system such as the BCL to locate the cancer in the breast. Other women may have breast cancers that cannot be felt, but are only identified by mammography or MRI. If the BCL proves to accurately localize breast cancer, it may be a useful guide for the surgeon for these other women.

Additionally, the investigators want to determine whether this technology can be successfully employed at multiple sites and what, if any, complications occur during surgery as a result of using this device. The BCL has been used in 19 patients at Dartmouth with no complications.

Conditions

Palpable Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Breast Cancer Locator (BCL)

Intervention Type: DEVICE

This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator, so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin.

Interventions

Breast Cancer Locator (BCL)

This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator, so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age > 18 years.

2. Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ.

3. Patient desire to undergo breast surgery (lumpectomy or non-skin sparing mastectomy).

4. Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.

5. The cancer enhances on prone breast MRI imaging

6. The cancer is visible on mammography.

Exclusion Criteria

1. Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.

2. Severe claustrophobia.

3. Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (creatinine > 2.0).

4. History of median sternotomy.

5. Pregnancy. Patient attestation that they are not pregnant will be acceptable.

6. Patients receiving neoadjuvant chemotherapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Richard J. Barth,Jr.

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard J Barth, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Lahey Hospital & Medical Center (Lahey Clinic)

Burlington, Massachusetts, United States

Cheshire Medical Center

Keene, New Hampshire, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

St. Joseph Hospital

Nashua, New Hampshire, United States

Countries

United States

Other Identifiers

D16196

Identifier Type: -

Identifier Source: org_study_id