Fluorescent Imaging of Nerves With Illuminare-1 During Surgery

Study Overview
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Brief Summary
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This study will test the safety of using Illuminare-1 during standard surgery for prostate cancer. The study researchers will test increasing doses of Illuminare-1 to find the dose that makes the nerve structures fluoresce (light up) but causes few or mild side effects. When the researchers find this dose, it will be tested in new groups of study participants to see whether surgery performed using Illuminare-1 guidance is better than surgery performed without intraoperative guidance. The researchers will also do tests to study the way the body absorbs, distributes, and gets rid of Illuminare-1. This study is the first to test Illuminare-1 in people. Illuminare-1 has received Fast Track designation from the US FDA.

Official Title
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Phase I Trial of Real-Time Intraoperative Fluorescent Imaging of Nerve Structures Using Illuminare-1, A Novel Myelin-Binding Fluorophore

Conditions
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Prostate Adenocarcinoma

Intervention / Treatment
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* Drug: Illuminare-1
* Device: Karl Storz D-Light C photodynamic diagnostic (PDD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older and capable of signing their own consent form Scheduled for minimally invasive radical prostatectomy with pelvic lymph node dissection Exclusion Criteria: Prior pelvic surgery or pelvic radiation therapy Known central nervous or peripheral nervous system disease or insult (including neurodegenerative diseases), current use of neurotoxic medications, or use of cytotoxic chemotherapy with known neurotoxicity within 1 month Exposure to investigational agents in the immediate 30 days before or 15 days after study drug administration Patients with significant renal dysfunction (<60 mL/min as assessed by the Cockcroft Gault calculation for creatinine clearance) Clinically significant hepatic/liver impairment (liver function tests more than 2x institutional normal upper limit) Exposure to phototoxic drugs such as St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, and tetracyclines, should be avoided. If safe to discontinue use for a limited time, patients may participate on this trial but will discontinue the use of the interfering drug for 5 half-lives before Illuminare-1 injection to permit full washout, as well as for 48 hours after administration of Illuminare-1.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a first-in-human, single-arm, open-label, dose-escalation phase I study to investigate the safety of Illuminare-1, a myelin-binding fluorescent small molecule in patients undergoing routine minimally invasive radical prostatectomy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Illuminare-1<br> | Drug: Illuminare-1<br>* Illuminare-1 at 3 dose levels in patients undergoing minimally invasive radical prostatectomy and bilateral pelvic lymph node dissection. Dose levels of the agent will be administered starting at 0.25mg/kg, with increases in dose between cohorts of no more than 0.5 mg/kg until a maximum dose of 2.25mg/kg is reached, if needed. At the dose identified to have the acceptable NMR and no associated DLTs, Illuminare-1 will be studied in up to 20 additional patients at this dose to optimize the imaging protocol and provide additional safety data.<br>Device: Karl Storz D-Light C photodynamic diagnostic (PDD)<br>* The Storz PDD system will be used as the hardware system in this phase 1 study due to its proven safety profile.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the safety of Illuminare-1 | Five patients will be observed at each dose level. If > 20% of patients within a cohort experience a grade 2 or higher adverse event that is considered attributable to the drug and clinically significant, dose escalation will be stopped at that level, and the prior dose level will be considered the MTD. DLTs will be defined using NCI-CTCAE 5.0. | up to 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluorescent Imaging, Illuminare-1, Myelin-Binding Fluorophore, 21-099