Fluorescent Imaging of Nerves With Illuminare-1 During Surgery

• Status: Recruiting
• Trial end date: 2023-10-04
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: Illuminare Biotechnologies

Criteria

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)

• 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 at least 48 hours, patients may participate on this trial but will discontinue use for 24 hours before and after administration of Illuminare-1.