Recruiting

Histolog Scanner

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07141121

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Histolog Scan

Study Details

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

Study ID

NCT07141121

Start date

May 13, 2025

Status verified date

Oct, 2025

Completion date

May 13, 2026

Anticipated

Primary completion date

May 13, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

78 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Monali Fatterpekar, PhD

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

Henry W. Jodka, BA

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

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Monali Fatterpekar, PhD

347-675-8024monali.fatterpekar@mountsinai.org

Henry W Jodka, BA

(203) 939-5115henry.jodka@mountsinai.org

Principal Investigator:

Ashutosh K Tewari

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Oct 7, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-10-07.