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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
78
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).
Icahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGProportion 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
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Count and percentage of specimens where the Histolog Dip impacted the ability to make final margin assessments in pathology
Time frame: Immediately after procedure