PRISM-NLM: Prostatectomy Intraoperative Surgical Margin Assessment With Non-linear Microscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Enrollment Success Rate
研究概览
简要总结
This study will evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing radical prostatectomy in participants with prostate cancer.
详细描述
This prospective, single-arm feasibility study is to evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing robot-assisted laparoscopic radical prostatectomy (RP) in participants with prostate cancer. A nonlinear microscope is a rapid imaging technology that can quickly image the surface of the prostate after it has been removed from the body to see if there is any cancer left behind.
The U.S. Food and Drug Administration (FDA) has not approved the NLM device for use in assessing radical prostatectomy surgical specimens but has been approved for other uses.
The research study procedures include screening for eligibility and standard of care radical prostatectomy surgery.
It is expected about 20 people will participate in this research study.
The National Institutes of Health is supporting this research study by providing study funds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Male or assigned male at birth (AMAB).
- •Initial diagnosis of localized PrCa.
- •Undergoing radical prostatectomy at BIDMC as part of their standard of care.
排除标准
- •No short-form available in the participant's language.
- •Cognitively unable to provide consent, in the opinion of the investigator.
- •Patients with evidence of unequivocal radiologic bilateral extraprostatic extension (EPE) on most recent MRI results.
- •Patients with >80 cc prostate volume (larger prostates would require potentially excessive evaluation time).
研究组 & 干预措施
Nonlinear Microscopy
Enrolled participants will undergo standard-of-care robot-assisted radical prostatectomy surgery utilizing NLM (Nonlinear Microscopy)
干预措施: Nonlinear Microscope (NLM) (Device)
结局指标
主要结局
Enrollment Success Rate
时间窗: From screening through informed consent completion (up to Day 0 or baseline visit).
Enrollment success rate is defined as the proportion of eligible participants enrolled relative to the prespecified enrollment target.
Retention Success Rate
时间窗: Up to 30 days post-surgery.
Retention success rate is defined as the probability of enrolled participants who completed the required study procedures and the follow-up period.
Technical and Workflow Feasibility Rate
时间窗: On the day of robot-assisted radical prostatectomy (Day 0)
Feasibility rate is defined as the proportion of enrolled participants undergoing robot-assisted radical prostatectomy for whom intraoperative NLM-based specimen margin evaluation meets all predefined feasibility criteria, including timely actionable pathologic feedback, effective real-time communication, and the ability to perform secondary NVB resection when indicated.
次要结局
- Concordance of Surgical Margin Status Between Intraoperative Nonlinear Microscopy (NLM) and Postoperative Formalin-Fixed Paraffin-Embedded Hematoxylin and Eosin (FFPE H&E) Assessment(Up to 30 days post-surgery.)
研究者
Peter Chang
Principal Invesitgator
Beth Israel Deaconess Medical Center