A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 8
- 主要终点
- The proportion of patients who had the localization wire placed within the cancer on the specimen mammogram
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ.
- •Patient desire to undergo breast surgery (lumpectomy or non-skin sparing mastectomy).
- •Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.
- •The cancer enhances on prone breast MRI imaging
- •The cancer is visible on mammography.
排除标准
- •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.
- •Patients receiving neoadjuvant chemotherapy.
结局指标
主要结局
The proportion of patients who had the localization wire placed within the cancer on the specimen mammogram
时间窗: 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).
次要结局
- Time from supine MRI to delivery of the Breast Cancer Locator (BCL) device to the surgeon(Within approximately 60 days following surgery)
- 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(Within approximately 60 days following surgery)
- Operative times (Average time per operation)(Within approximately 60 days following surgery)
- Whether the study Radiologist can accurately define boundaries of the tumor from the supine MRI images(Within approximately 60 days following surgery)
- Lumpectomy specimen volumes(Within approximately 60 days following surgery)
- The tumor margins, which the pathologist measures (as the distance from the tumor to the specimen edge)(Within approximately 60 days following surgery)
- Complications from surgery(Within approximately 60 days following surgery)
- Surgeon satisfaction with the technical aspects of surgery guided by the Breast Cancer Locator(Within approximately 60 days following surgery)
研究者
Richard J. Barth,Jr.
MD
Dartmouth-Hitchcock Medical Center