Clinical trial NCT03573661: A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers
Official title: A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palpable Breast Cancer
Keywords: Breast Conserving Surgery
Breast Imaging
Breast Cancer Locator
Supine MRI
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: The proportion of patients who had the localization wire placed within the cancer on the specimen mammogram
timeFrame: Within approximately 60 Days post-surgery (all measures are collected by the time of patient follow-up visit within approximately 60 days after surgery, and recorded by the surgeon and radiologist in Case Report Forms (CRF forms).
Secondary outcomes:
measure: Whether the study Radiologist can accurately define boundaries of the tumor from the supine MRI images
timeFrame: Within approximately 60 days following surgery
measure: Time from supine MRI to delivery of the Breast Cancer Locator (BCL) device to the surgeon
timeFrame: Within approximately 60 days following surgery
measure: Whether the BCL allowed the surgeon to successfully mark in/on the breast skin surface the items he or she needs to see during the surgery, including tumor edges and locations where wires will be placed
timeFrame: Within approximately 60 days following surgery
measure: Lumpectomy specimen volumes
timeFrame: Within approximately 60 days following surgery
measure: Operative times (Average time per operation)
timeFrame: Within approximately 60 days following surgery
measure: The tumor margins, which the pathologist measures (as the distance from the tumor to the specimen edge)
timeFrame: Within approximately 60 days following surgery
measure: Complications from surgery
timeFrame: Within approximately 60 days following surgery
measure: Surgeon satisfaction with the technical aspects of surgery guided by the Breast Cancer Locator
timeFrame: Within approximately 60 days following surgery
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center (Lahey Clinic)
state: Massachusetts
city: Keene
country: United States
facility: Cheshire Medical Center
state: New Hampshire
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Nashua
country: United States
facility: St. Joseph Hospital
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Richard J Barth, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References: