Feasibility of Timesaving When Using Histolog Confocal Laser Endomicroscopy for Margin Assessment in Prostatectomy Specimen
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Proportion of Surgeries with Histolog Scanner Attributable Time-Saving Greater Than 20 Minutes
研究概览
简要总结
This study investigates a new, faster way to find cancer cells on the surface of the prostate during radical prostatectomy surgery. A recently FDA-approved device, called the Histolog Scanner, gives high-resolution imaging of the surface of fresh tissue using ultra-fast confocal microscopy, which allows physicians to make surgical decisions quickly.
详细描述
The goal of this time saving feasibility study is to gain early insights into whether Histolog Scanner can maintain the integrity and safety of NeuroSafe margin assessment while alleviating the heavy time burden of NeuroSafe in the US setting before starting a larger clinical trial. This way, patients can be offered optimal nerve sparing without adding to the administrative burden and cost associated with NeuroSafe. What is new about the study is that the researchers intend to do a cost and time economics analysis using United States market prices that will inform discussions in the future about the utility of this device in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Localized or locally advanced prostate cancer D'Amico intermediate or high-risk disease.
- •Indicated for robot-assisted radical prostatectomy
- •Treatment naive.
- •Age ≥ 18 years.
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Patients who have received pelvic radiation previously for prostate cancer or any other malignancy.
- •Patients who have previously received androgen deprivation or other hormonal treatments, or focal therapy of prostate cancer prior to radical prostatectomy.
- •Patients with D'Amico Criteria low risk prostate cancer.
研究组 & 干预措施
Patients undergoing robotic-assisted radical prostatectomy
Patients undergo standard of care (SOC) robotic-assisted radical prostatectomy. The patients' removed prostates are then evaluated with the Histolog Scanner. Patients also undergo SOC blood sample collection, rectal examination, MRI, and micro ultrasound imaging, as well as have their medical records reviewed throughout the trial.
干预措施: Histolog Scan (Device)
结局指标
主要结局
Proportion of Surgeries with Histolog Scanner Attributable Time-Saving Greater Than 20 Minutes
时间窗: Immediately after procedure
Defined as a positive difference of time taken using NeuroSafe technique vs time taken by Histolog scanner in margin assessment.
次要结局
- Agreement Between Histolog and Final Histopathology Assessment(Immediately after procedure)
- System Usability Scale (SUS)("Baseline" or "Day 1" and through study completion, an average of 1 year)
- Pathologist Usability Scale (PUS) score("Baseline" or "Day 1" and through study completion, an average of 1 year)
- Count and percentage of specimens where the Histolog Dip impacted the ability to make final margin assessments in pathology(Immediately after procedure)
研究者
Ashutosh Kumar Tewari
Professor and System Chairman, Department of Urology
Icahn School of Medicine at Mount Sinai