Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Breast Diseases

Skin Diseases

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.

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.

Breast Cancer Locator (BCL)

Richard J Barth, Jr., MD

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.

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.

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

Yes/No answer from Radiologist. Final measure will be % of cases rated Yes (wire deployed within the cancer on specimen mammogram).

Yes/No answer from Radiologist. Final measure will be % of cases rated Yes (tumor segregated accurately from supine MRI). The data is recorded by the radiologist on the CRF form.

Unit of measure is in days. Final measure will be average days to delivery among all patients. The data is recorded by the surgeon on the CRF form.

Yes/No answer from Surgeon. Final measure will be % of cases rated Yes (BCL enabled surgeon to successfully place all cues). The data is recorded by the surgeon on the CRF form.

Unit of measure is in mL, calculated by water displacement. Final measure will be average volume (mL) among all patients. The data is recorded by the study sponsor, Cairn Surgical, on the CRF form.

Unit of measure is in minutes. Final measure will be average operative time (min.) among all patients. Data is collected by the surgeon from operative notes and placed in the CRF form.

Unit of measure is in cm. Final measure will be average margin (in cm) among all patients. Data is collected by the surgeon from the pathology report and reported in the CRF form.

Surgeon to list any complications - which could include infections or bruising. Final measure will be % of patients with complications. Data is collected from the surgeon either post-operatively, if there were operative complications; or at the post-operative follow-up appointment with the patient, if she reports any complications then. It is also possible this data could be collected at any time between surgery and follow up appointment by the patient calling the surgeon's office to report it. The surgeon records this data in the CRF form.

Yes/No answer. Final measure will be % of surgeons who say Yes to satisfaction with the procedure. Data is collected from the surgeon and reported in the CRF form.

Dartmouth-Hitchcock Medical Center

This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the 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.

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.

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.

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

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.

The positive margin rate as defined by standard pathologic evaluation of the entire specimen.

Distances will be measured and descriptive statistics will be employed.

Volumes will be measured and descriptive statistics will be employed. The specimen volume is determined by recording the water displacement and specimen scanning.

Regular investigator assessment and regular laboratory testing

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 the procedure.

Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the 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.

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.

Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers	NCT03573661	Palpable Breast...	Breast Cancer L...	18 Years -	Dartmouth-Hitchcock Medical Center
A Study to Evaluate the Accuracy of a Breast Cancer Locator (BCL) in Patients With Palpable Cancers	NCT02550210	Breast Cancer	Breast Cancer L...	18 Years - 99 Years	Dartmouth-Hitchcock Medical Center
A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers	NCT03573661	Palpable Breast...	Breast Cancer L...	18 Years -	Dartmouth-Hitchcock Medical Center

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