Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 43
- 主要终点
- Positive margin rate
研究概览
简要总结
This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Subjects will be randomized to breast conserving surgery (BCS) utilizing either the BCL or wire localization (WL) to guide surgery.
详细描述
The BCL System is intended to be used to guide a surgeon when performing partial mastectomy for breast cancer and to minimize positive margins. The purpose of this study is to provide evidence that the BCL is safe, effective, and non-inferior to the standard of care (WL) in the removal of non-palpable invasive breast cancer and DCIS.
Investigators in the intervention group will be provided with a three dimensional (3D) image of the cancer in the breast which allows them to visualize the closest distance from the tumor to the skin and the chest wall and quantifies those distances. Investigators will also use a BCL, which is a patient specific, plastic, bra-like form that is transiently placed on the breast prior to surgery and allows the Investigator to mark the projected edges of the tumor on the breast skin and to place bracketing wires inside the breast which define the center of the cancer and distances 1 cm from the tumor edges defined by pre-operative supine MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Pathologist will be blinded to the study assignment (BCL vs. WL)
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
- •Female gender
- •Age > 18 years
- •Histologic diagnosis of invasive breast cancer or DCIS
- •The surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation
- •The tumor is unifocal or multifocal with satellite lesions < or = 2 cm from primary tumor
- •The tumor enhances on prone breast MRI imaging
- •The tumor is ≥ 1 cm in diameter on prone breast MRI
- •Subject and surgeon agree to perform BCS
- •Subject voluntarily provides informed consent
排除标准
- •Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes
- •Severe claustrophobia that precludes prone or supine MRI
- •Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy
- •Compromised renal function including chronic, severe kidney disease (GFR < 30 ml/min/1.73m2), or acute kidney injury
- •Pregnancy - In women of childbearing potential, a urine pregnancy test will be performed
- •Subjects who have received or plan to receive neoadjuvant chemotherapy
- •Sternal notch to nipple distance of > 32 cm as measured in a sitting or standing position
- •Measurement of widest circumference around breasts and arms > 135 cm for sites using 60cm bore scanners, and measurement of widest circumference around breasts and arms >145 cm for sites using 70 cm bore scanners
- •Subjects with known allergy to materials present in the device
- •Use of localization with devices other than a localization wire, including intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices (MarginProbe)
- •Subject would require > 2 localization wires, if randomized to standard of care
- •Subjects with multicentric tumors (additional tumors > 2 cm from primary)
- •Subject would require chest wall muscle nerve block as part of the operation
结局指标
主要结局
Positive margin rate
时间窗: At completion of study recruitment, approximately 18 months after first subject enrolled
To provide evidence that the positive margin rate following BCS using the BCL is not inferior to the standard of care (WL) for surgical guidance
次要结局
- Rate of additional shave biopsies(At completion of study recruitment, approximately 18 months after first subject enrolled)
- Costs of care(At completion of study recruitment, approximately 18 months after first subject enrolled)
- Re-excision rate(At completion of study recruitment, approximately 18 months after first subject enrolled)
- Specimen volumes(At completion of study recruitment, approximately 18 months after first subject enrolled)
- Operative times(At completion of study recruitment, approximately 18 months after first subject enrolled)
- Adverse event rate(At completion of study recruitment, approximately 18 months after first subject enrolled)
- Cancer localization rate(At completion of study recruitment, approximately 18 months after first subject enrolled)