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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Histolog Scan

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monali Fatterpekar, PhD; Phone Number: +1 (347) 675-8024; Email: monali.fatterpekar@mountsinai.org
• Study Contact Backup: Name: Henry W. Jodka, BA; Phone Number: +1 203-939-5115; Email: henry.jodka@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Monali Fatterpekar, PhD; Phone Number: 347-675-8024; Email: monali.fatterpekar@mountsinai.org
      • Contact: Henry W Jodka, BA; Phone Number: (203) 939-5115; Email: henry.jodka@mountsinai.org
      • Principal Investigator: Ashutosh K Tewari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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 care (SOC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement Between Histolog and Final Histopathology Assessment	The Kappa statistic (Cohen's Kappa) will be used to assess agreement between Histolog and final histopathology assessment. 95% CI will be calculated using the Wilson's method without continuity correction.	Immediately after procedure
System Usability Scale (SUS)	System Usability Scale (SUS) ranges between 8-40. Each question asks about ease of use of the Histolog Scanner, and the operator answers each of the 8 questions on a scale of 1 (strongly disagree) to 5 (strongly agree). Any SUS score greater than or equal to 32 will be interpreted as high usability. Operator will be asked to complete after the completion of every 10 procedures and again after the final procedure.	"Baseline" or "Day 1" and through study completion, an average of 1 year
Pathologist Usability Scale (PUS) score	Pathologist Usability Scale (PUS) ranges between 6-30. Each question asks about the ease of use of the Histolog Scanner, and the pathologist answers each of the 6 questions on a scale of 1 (strongly disagree) to 5 (strongly agree). Any PUS score greater than or equal to 25 will be interpreted as high pathologist usability. Pathologist will be asked to complete after the completion of every 10 procedures and again after the final procedure.	"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	Count and percentage of specimens where the Histolog Dip impacted the ability to make final margin assessments in pathology	Immediately after procedure

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: SamanTree Medical SA
• Investigators: Principal Investigator: Ashutosh K. Tewari, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2025
• Primary Completion (Estimated): May 13, 2026
• Study Completion (Estimated): May 13, 2026

Study Registration Dates

• First Submitted: July 31, 2025
• First Submitted That Met QC Criteria: August 18, 2025
• First Posted (Estimated): August 26, 2025

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 6, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Feasibility; Radical Prostatectomy; Confocal Microscopy; Surgical Margins; Histolog Scanner; NeuroSafe
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings; Prostatic Neoplasms; Margins of Excision
• Other Study ID Numbers: STUDY-24-01611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Specify Other Time FrameTBD

IPD Sharing 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).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No