The ClearCoast™ Magnetic Resonance Outcome Post Marketing Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- ClearCoast™ Success rate
研究概览
简要总结
Post Marketing Surveillance (PMS) study. Up to 93 patients undergoing breast conserving surgery will be enrolled in a prospective, single center, non-randomized controlled study, and a corresponding number of historical patients that underwent BCS will serve as the historical control group, accounting for a 1:1 ratio. All study patients and the patients in the historical control group will be required to meet the study eligibility criteria.
BCS will be performed with the routine standard of care (SOC), including intra-operative methods used to improve margin assessment. In addition to SOC process, the main specimen from patients found eligible will be scanned in the ClearCoast™ system. The surgeon will utilize the information from the ClearCoast images in his margin assessments evaluation which includes the diffusion at the surface of a particular aspect (suggesting irregular tissue at the specimen's surface), and decide whether to excise additional tissue. The decision-making process including MR images interpretation and the surgical decisions will be evaluated and documented. Following procedure, routine histopathology examination will be performed accompanied by the ClearCoast optical and parametric maps.
This study is a controlled design, in which subjects previously having undergone BCS by the same surgeons, will serve as the historical control group, comparing the following endpoints:
- Complete surgical re-excision rate
- Total excised breast tissue volume
The study Control group is composed of historical data from patients previously undergone BCS, under the same site SOC surgical practice, practicing surgeons, and study eligible criteria. This allows reducing inter-group variability and bias.
A device operator trained by ClearCut Medical will operate the device throughout the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 invasive and/or in situ carcinoma of the breast, undergoing primary lumpectomy (partial mastectomy) procedure
- •Patient is willing and capable to provide written Informed Consent Form (ICF)
排除标准
- •Prior surgical procedure in the same breast within 12 months prior to the surgery date
- •Recurrent breast cancer surgery
- •Neoadjuvant chemotherapy and/or neoadjuvant hormone therapy
- •Previous radiation therapy in the operated breast
- •Patient has subglandular breast implants in the operated breast
- •moribund patient and/or patient with comorbidities, per principal investigator discretion
- •Participating in any other investigational study for either drug or device which might influence collection of valid data under this study.
- •Intraoperative:
- •Specimen undergoing pathological specimen assessment (e.g. by frozen section, imprint cytology or gross assessment by sectioning), resulting in deformation of specimen shape/tissue properties (e.g. Formalin conservation)
- •Specimen dimension is larger than the Tissue container volume (200cc)
- •Inability to define aspect color/orientation and/or margin border
结局指标
主要结局
ClearCoast™ Success rate
时间窗: 6 months
the success of the ClearCoast™ system indicating abnormal margins of breast tissue specimen intra-operatively. This endpoint compares the proportion of patients that undergo a re-excision surgery following the primary lumpectomy procedure between the two groups.
次要结局
- Secondary Outcome - Re-excision rate(1 year)