Prostate Cancer Clinical Trial

Fluorescent Imaging of Nerves With Illuminare-1 During Surgery

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.

View Eligibility Criteria

Eligibility 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)
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 is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT04983862

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 6 Locations for this study

See Locations Near You

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge New Jersey, 07920, United States More Info
Timothy Donahue, MD
Contact
646-422-4567
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown New Jersey, 07748, United States More Info
Timothy Donahue, MD
Contact
646-422-4567
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale New Jersey, 07645, United States More Info
Timothy Donahue, MD
Contact
646-422-4567
Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities)
Commack New York, 11725, United States More Info
Timothy Donahue, MD
Contact
646-422-4567
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison New York, 10604, United States More Info
Timothy Donahue, MD
Contact
646-422-4567
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Timothy Donahue, MD
Contact
646-422-4567

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT04983862

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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