Feasibility of Timesaving When Using Histolog Confocal Laser Endomicroscopy for Margin Assessment in Prostatectomy Specimen

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Histolog Scan
  Upon prostate removal, the prostate is taken to the Histolog scanner, dipped in proprietary fluorescent dye, rinsed with saline, and then scanned on five different sides. This involves simply placing the prostate on the surface of the scanner and acquiring images on each side, giving a high-resolution (cellular level) microscopic imaging of the prostate's surfaces. Once images are collected, the prostate is returned to the pathology lab to undergo the NeuroSafe procedure, which is standard of ca

Первичные конечные точки

• Proportion of Surgeries with Histolog Scanner Attributable Time-Saving Greater Than 20 Minutes [Срок оценки: Immediately after procedure]

Вторичные конечные точки (4)

• Agreement Between Histolog and Final Histopathology Assessment [Срок оценки: Immediately after procedure]
• System Usability Scale (SUS) [Срок оценки: "Baseline" or "Day 1" and through study completion, an average of 1 year]
• Pathologist Usability Scale (PUS) score [Срок оценки: "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 [Срок оценки: Immediately after procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Icahn School of Medicine at Mount Sinai — New York

Идентификаторы

NCT: NCT07141121 · STUDY-24-01611

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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