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NCT Number: NCT07141121

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Margins of Excision Morphological and Microscopic Findings Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

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

    Time frame: Immediately after procedure

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

Secondary outcomes

  1. Agreement Between Histolog and Final Histopathology Assessment

    Time frame: Immediately after procedure

    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.

  2. System Usability Scale (SUS)

    Time frame: "Baseline" or "Day 1" and through study completion, an average of 1 year

    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.

  3. Pathologist Usability Scale (PUS) score

    Time frame: "Baseline" or "Day 1" and through study completion, an average of 1 year

    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.

  4. Count and percentage of specimens where the Histolog Dip impacted the ability to make final margin assessments in pathology

    Time frame: Immediately after procedure

    Count and percentage of specimens where the Histolog Dip impacted the ability to make final margin assessments in pathology

Study contacts

Contact information is provided by the study sponsor or research team.

Henry W. Jodka, BA

CONTACT

[email protected]

203-939-5115 ext. +1

Monali Fatterpekar, PhD

CONTACT

[email protected]

(347) 675-8024 ext. +1

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • SamanTree Medical SA

Registry information

Acronym: IMARHGIN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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