Histolog Scan for Prostate Cancer

(IMARHGIN Trial)

Overseen By Henry W. Jodka, BA

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Hormonal treatments

Disqualifiers: Pelvic radiation, Low risk cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Histolog Scanner, to determine if it can quickly detect cancer cells on the prostate's surface during surgery. The goal is to assist doctors in making faster decisions while operating. It targets individuals with prostate cancer who have not yet undergone treatment and are scheduled for robot-assisted prostate surgery. Participants should have intermediate or high-risk prostate cancer that remains localized within the prostate area. As an unphased trial, this study allows participants to contribute to innovative research that could improve surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that participants have not received certain prostate cancer treatments before joining.

What prior data suggests that the Histolog Scanner is safe for use in prostate cancer surgery?

Research shows that the Histolog Scanner, recently approved by the FDA, helps detect cancer cells on the prostate's surface during surgery. FDA approval indicates evidence of its safety for humans. The device employs ultra-fast confocal microscopy, a method tested to provide clear tissue images, aiding doctors in making quicker decisions during surgeries.

Although specific safety data on the Histolog Scanner is not available in the provided sources, its approval suggests thorough safety evaluation. Approval typically indicates the device is well-tolerated and does not cause significant harm. However, discussing any concerns with the study team is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Histolog Scan for prostate cancer because it offers a new way to evaluate removed prostates after surgery. Unlike current treatments that focus on removing the cancerous prostate via robotic-assisted radical prostatectomy, the Histolog Scan provides detailed imaging and analysis of the prostate tissue right after it's removed. This method could potentially give doctors more immediate information about the cancer, leading to better-tailored follow-up treatments. By incorporating advanced imaging technology, the Histolog Scan might improve the accuracy of post-surgical assessments compared to standard procedures.

What evidence suggests that the Histolog Scan is effective for detecting prostate cancer?

Research shows that the Histolog Scanner can effectively detect cancer cells on the prostate's surface. In one study, the scanner demonstrated a sensitivity of 86% and a specificity of 96%. Sensitivity measures how well the test detects actual cancer cases, while specificity measures how well it identifies non-cancer cases. Thus, the scanner accurately identifies both cancerous and non-cancerous tissue. In this trial, patients undergoing robotic-assisted radical prostatectomy will have their removed prostates evaluated with the Histolog Scanner. The device uses detailed imaging to assist doctors in making quick decisions during surgery, potentially improving outcomes for prostate cancer patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Ashutosh K. Tewari, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals undergoing radical prostatectomy surgery for prostate cancer. It aims to test a new device's ability to quickly identify cancer cells on the prostate surface during surgery.

Inclusion Criteria

I am recommended to undergo a robotic surgery for prostate removal.

I have not received any treatment for my condition.

I am 18 years old or older.

Exclusion Criteria

I have had hormone therapy or focal therapy for prostate cancer before surgery.

I have had radiation therapy in the pelvic area for cancer.

My prostate cancer is considered low risk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure and Imaging

Patients undergo robotic-assisted radical prostatectomy and the removed prostates are evaluated with the Histolog Scanner. Standard of care blood sample collection, rectal examination, MRI, and micro ultrasound imaging are also performed.

Immediately after procedure

Usability Assessment

System Usability Scale (SUS) and Pathologist Usability Scale (PUS) are assessed after every 10 procedures and again after the final procedure.

Through study completion, an average of 1 year

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including the impact of the Histolog Dip on final margin assessments.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Histolog Scan

Trial Overview The intervention being studied is the Histolog Scanner, an FDA-approved device that uses confocal microscopy to provide high-resolution images of fresh tissue surfaces in real-time during surgery.

How Is the Trial Designed?

Group I: Patients undergoing robotic-assisted radical prostatectomy Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

SamanTree Medical SA

Industry Sponsor

Trials

4

Recruited

380+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9947052/

Histopathological results of radical prostatectomy ... Our data show that the majority of patients who were diagnosed with PCa at a very young age had favorable histopathological RP characteristics.

2. ascopubs.org ascopubs.org/doi/10.1200/CCI-24-00292

Artificial Intelligence–Based Digital Histologic Classifier for ... Accurate risk stratification and prognostication are essential in the management of patients with clinically localized prostate cancer (CaP). It ...

3. nature.com nature.com/articles/s44303-023-00005-z

Artificial intelligence unravels interpretable malignancy ... We developed a novel grading system for PCa and utilized artificial intelligence (AI) and multi-institutional international datasets from 2647 PCa patients.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11707496/

Accuracy of the LaserSAFE technique for detecting positive ... utilised the Histolog scanner on NeuroSAFE‐like prostate shavings and reported a sensitivity of 86% and specificity of 96%, aligning closely ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12071-6

Advantage of whole-mount histopathology in prostate cancer Studies have demonstrated the efficacy of Prostate Imaging Reporting and Data System (PI-RADS) in PCa diagnosis with WMH registration, with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07141121

Feasibility of Timesaving When Using Histolog Confocal ... This study investigates a new, faster way to find cancer cells on the surface of the prostate during radical prostatectomy surgery. A recently ...

7. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/am-pdf/10.1111/bju.16239

The LaserSAFE te - BJU International Multivariable model to assess the association between operative time and risk of overall and severe complications (Clavien-Dindo score ≥3) within 3 months.

8. withpower.com withpower.com/trial/phase-prostatic-neoplasms-4-2025-02a5c

Histolog Scan for Prostate Cancer (IMARHGIN Trial) 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 ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0893395222008699

Article Nonlinear microscopy for detection of prostate cancer This study evaluates the accuracy of prostate cancer detection in a blinded reading of NLM images compared with the gold standard of formalin-fixed, paraffin- ...