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

NCT07141121 | Recruiting DMC FDA Device

• 1 other identifier: STUDY-24-01611
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Confocal Microscopy; Histolog Scanner; NeuroSafe; Surgical Margins; Feasibility; Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Proportion of Surgeries with Histolog Scanner Attributable Time-Saving Greater Than 20 Minutes

  Defined as a positive difference of time taken using NeuroSafe technique vs time taken by Histolog scanner in margin assessment.

  Immediately after procedure

Secondary Outcomes (4)

• 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

Study Arms (1)

Patients undergoing robotic-assisted radical prostatectomy

EXPERIMENTAL

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.

Device: Histolog Scan

Interventions

Histolog Scan DEVICE

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 care (SOC).

Patients undergoing robotic-assisted radical prostatectomy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is looking at post-surgical specimens for patients with prostate cancer, so the researchers are only looking at a male population.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• SamanTree Medical SA: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashutosh K. Tewari, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monali Fatterpekar, PhD

CONTACT

(347) 675-8024; monali.fatterpekar@mountsinai.org

Henry W. Jodka, BA

CONTACT

203-939-5115; henry.jodka@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and System Chairman, Department of Urology

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 26, 2025
• Study Start: May 13, 2025
• Primary Completion: May 13, 2026
• Study Completion: May 13, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Specify Other Time FrameTBD
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. For individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in the University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (to be determined).

Locations

US (1)