Fluorescent Imaging of Nerves With Illuminare-1 During Surgery

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.

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Key information

Conditions

Prostate Adenocarcinoma

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Illuminare-1

Drug

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 0.75 mg/kg until a maximum dose of 3.0mg/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.

Karl Storz D-Light C photodynamic diagnostic (PDD)

Device

The Storz PDD system will be used as the hardware system in this phase 1 study due to its proven safety profile.

Primary outcomes

determine the safety of Illuminare-1

Time frame: up to 45 days

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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

Illuminare Biotechnologies

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Jul 30, 2021
Registry last updated: Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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