MarginProbe® System U.S. Post-Approval Study Protocol CP-07-001
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 440
- 试验地点
- 11
- 主要终点
- Diagnostic accuracy at the margin level
研究概览
简要总结
The study objective is to determine the MarginProbe® System's diagnostic accuracy at the margin level and impact on Positive Margin* Presence originating from the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery.
*A positive margin is defined in this study as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked surface
详细描述
This is a prospective, multicenter, randomized (1:1), double arm, controlled study, in which subjects undergoing breast excision (lumpectomy) for carcinoma of the breast will be randomized to either standard of care with additional inspection ('SOC + Additional inspection' arm) or standard of care with MarginProbe as an adjunct ('SOC + Device' arm).
The MarginProbe is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision. It will be used by the surgeon during lumpectomy procedures only in patients randomized to the "Device+SOC" arm.
Randomization will take place following the excision of the main ex-vivo lumpectomy specimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Women histologically diagnosed with carcinoma of the breast
- •Women with non-palpable malignant lesions, requiring image guided localization.
- •Undergoing lumpectomy (partial mastectomy) procedure
- •Age 18 years or more
- •Signed ICF
排除标准
- •Multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast)
- •Bilateral disease (diagnosed cancer in both breasts)
- •Neo-adjuvant systemic therapy
- •Previous radiation in the operated breast
- •Prior surgery in the same site in the breast
- •Woman histologically diagnosed by an open biopsy procedure
- •Implants in the operated breast
- •Pregnancy
- •Lactation
- •Participating in any other investigational study for either drug or device which could influence collection of valid data under this study
- •Patients for whom complete cavity shaving is planned (sites where this is the routine practice of the investigator will also be excluded from participation in the study)
研究组 & 干预措施
SOC + Device
The surgeon will perform routine standard of care lumpectomy with adjunctive MarginProbe device use on the main ex-vivo lumpectomy specimen.
干预措施: Margin Probe (Device)
SOC + Additional Inspection
The surgeon will perform routine standard of care lumpectomy with additional inspection on the main ex-vivo lumpectomy specimen.
干预措施: Control: Additional inspection (Other)
结局指标
主要结局
Diagnostic accuracy at the margin level
时间窗: Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
Sensitivity and Specificity at the margin level;
Incomplete Surgical Resection (ISR )
时间窗: Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
ISR - Positive Margin on the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery, that was not addressed by taking a shaving(s) corresponding to the positive margin(s).
次要结局
- Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery(Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date)
- Repeat lumpectomy and mastectomy rate(Participants will be followed for 2-5 weeks (average))
- Repeat lumpectomy rate(Participants will be followed for 2-5 weeks (average))
- Cosmesis evaluation(participants will be followed until 6 months ± 1 month after last surgical treatment visit, an avarage of of 8 months following initial lumpectomy)
- Diagnostic Accuracy at the Patient Level (ignoring location)(Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date)