An interventional study of Histolog Scan in Prostate Cancer, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-07.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Other
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 78 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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).
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.
Time frame: Immediately after procedure
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.
Time frame: 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.
Time frame: "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.
Time frame: "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
Time frame: Immediately after procedure
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol
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Icahn School of Medicine at Mount Sinai