Feasibility of Timesaving When Using Histolog Confocal Laser Endomicroscopy for Margin Assessment in Prostatectomy Specimen
Recruiting · NCT07141121 · Interventional (participants receive a specific treatment) · Lead sponsor: Icahn School of Medicine at Mount Sinai
View the official record on ClinicalTrials.gov →Interventions studied
Histolog Scan
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Icahn School of Medicine at Mount Sinai - New York, New York, United States