Clinical trial · Interventional
Feasibility of Timesaving When Using Histolog Confocal Laser Endomicroscopy for Margin Assessment in Prostatectomy Specimen
NCT07141121CI-TRIAL-00096385IMARHGINrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Histolog Scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients undergoing robotic-assisted radical prostatectomy
- description
- 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.
- interventionNames
- Device: Histolog Scan
Primary outcomes (1)
- measure
- Proportion of Surgeries with Histolog Scanner Attributable Time-Saving Greater Than 20 Minutes
- timeFrame
- Immediately after procedure
- description
- Defined as a positive difference of time taken using NeuroSafe technique vs time taken by Histolog scanner in margin assessment.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.