Feasibility of Timesaving When Using Histolog Confocal Laser Endomicroscopy for Margin Assessment in Prostatectomy Specimen
Status
RECRUITING
Phase
NA
Age
≥ 18 Years
Enrollments
78Conditions
Prostate CancerSummary
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.
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Monali Fatterpekar, PhD
- 347-675-8024
- [email protected]
Principal Investigator
- Ashutosh K. Tewari, MD
Eligibility Criteria
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
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 ScanDescription:
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).
Timeline
Last Updated
October 7, 2025Start Date
August 26, 2025Today
March 13, 2026Completion Date ( Estimated )
May 13, 2026
Sponsors of this trial
Lead Sponsor
Icahn School of Medicine at Mount SinaiCollaborating Sponsors
SamanTree Medical SA
RECRUITING 
18 - 80 Years