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

Mount Sinai Health System

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Device: Histolog Scan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07141121

STUDY-24-01611

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 78 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Patients undergoing robotic-assisted radical prostatectomy

Experimental group

Description:

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.

Treatment:

Device: Histolog Scan