Feasibility of Timesaving When Using Histolog Confocal Laser Endomicroscopy for Margin Assessment in Prostatectomy Specimen
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Monali Fatterpekar, PhD
monali.fatterpekar@mountsinai.org
(347) 675-8024
Backup
Henry W. Jodka, BA
henry.jodka@mountsinai.org
203-939-5115
Time Frame
Start Date: 2025-05-13
Estimated Completion Date: 2026-05-13
Participants
Target number of participants: 78
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: SamanTree Medical SA
Leads: Icahn School of Medicine at Mount Sinai