Fluorescent Imaging of Nerves With Illuminare-1 During Surgery
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Illuminare-1
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Drug: Illuminare-1
Illuminare-1 at 3 dose levels in patients undergoing minimally invasive radical prostatectomy and bilateral pelvic lymph node dissection. Three dose levels will be used: 0.25mg/kg, 0.5mg/kg, and 1.0mg/kg. Once the imaging dose of Illuminare-1 is established at a no-DLT level, an expansion cohort of 20 patients will be evaluated at this dose.
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.
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Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years or older and capable of signing their own consent form
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Scheduled for minimally invasive radical prostatectomy with pelvic lymph node dissection
Exclusion Criteria:
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Prior pelvic surgery or pelvic radiation therapy
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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
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Exposure to investigational agents in the immediate 30 days before or 15 days after study drug administration
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Patients with significant renal dysfunction (<60 mL/min as assessed by the Cockcroft Gault calculation for creatinine clearance)
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Clinically significant hepatic/liver impairment (liver function tests more than 2x institutional normal upper limit)
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey | United States | 07920 |
2 | Memorial Sloan Kettering Monmouth (Limited protocol activities) | Middletown | New Jersey | United States | 07748 |
3 | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey | United States | 07645 |
4 | Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities) | Commack | New York | United States | 11725 |
5 | Memorial Sloan Kettering Westchester (Limited protocol activities) | Harrison | New York | United States | 10604 |
6 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- Illuminare Biotechnologies
Investigators
- Principal Investigator: Timothy Donahue, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-099