NCT Number: NCT03573661
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Lahey Hospital & Medical Center (Lahey Clinic), Burlington, Massachusetts, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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).
Yes/No answer from Radiologist. Final measure will be % of cases rated Yes (wire deployed within the cancer on specimen mammogram).
Time frame: Within approximately 60 days following surgery
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.
Time frame: Within approximately 60 days following surgery
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.
Time frame: Within approximately 60 days following surgery
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.
Time frame: Within approximately 60 days following surgery
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.
Time frame: Within approximately 60 days following surgery
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.
Time frame: Within approximately 60 days following surgery
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.
Time frame: Within approximately 60 days following surgery
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.
Time frame: Within approximately 60 days following surgery
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
Other
Acronym: BCL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
