Fluorescent Imaging of Nerves with Illuminare-1 During Surgery
- Conditions
- Prostate Adenocarcinoma
- Interventions
- Device: Karl Storz D-Light C photodynamic diagnostic (PDD)
- Registration Number
- NCT04983862
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 50
- 18 years or older and capable of signing their own consent form
- Scheduled for minimally invasive radical prostatectomy with pelvic lymph node dissection
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Illuminare-1 Karl Storz D-Light C photodynamic diagnostic (PDD) - Illuminare-1 Illuminare-1 -
- Primary Outcome Measures
Name Time Method determine the safety of Illuminare-1 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited protocol activities)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States