Fluorescent Imaging of Nerves With Illuminare-1 During Surgery

Prostate Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04983862
• Other study ID #: 21-099
• Status: Recruiting
• Phase: Phase 1
• Start date: October 4, 2021
• Est. completion date: October 4, 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Timothy Donahue, MD
• Phone: 646-422-4567
• Email: donahuet[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 4, 2025
• Est. primary completion date: October 4, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma

Intervention

Drug:
• Illuminare-1
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.

Device:
• Karl Storz D-Light C photodynamic diagnostic (PDD)
The Storz PDD system will be used as the hardware system in this phase 1 study due to its proven safety profile.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	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 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 Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Illuminare Biotechnologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center