Fluorescent Imaging of Nerves With Illuminare-1 During Surgery

NCT04983862 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: 21-099
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 6

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.

Conditions

Prostate Adenocarcinoma

Keywords

Fluorescent Imaging; Illuminare-1; Myelin-Binding Fluorophore; 21-099

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Illuminare-1

EXPERIMENTAL

Drug: Illuminare-1; Device: Karl Storz D-Light C photodynamic diagnostic (PDD)

Interventions

Illuminare-1 DRUG

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 0.75 mg/kg until a maximum dose of 3.0mg/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.

Illuminare-1

Karl Storz D-Light C photodynamic diagnostic (PDD) DEVICE

The Storz PDD system will be used as the hardware system in this phase 1 study due to its proven safety profile.

Illuminare-1

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older and capable of signing their own consent form
• Scheduled for minimally invasive radical prostatectomy with pelvic lymph node dissection

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Illuminare Biotechnologies: collaborator

Study Sites (6)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Gold SA, Pere MM, Assel M, Doudt AD, Durdin TD, Silagy AW, Dean LW, Recabal P, Levine E, Burke A, Ragupathi G, Marzabadi MR, Yao ZK, Yang G, Yang G, Ouerfelli O, McCarter M, Chen X, Tzatha E, Coleman JA, Goh AC, Smith RC, Ehdaie B, Vickers AJ, Scardino PT, Eastham JA, Laudone VP, Donahue TF. Rizedisben in Minimally Invasive Surgery: A Nonrandomized Clinical Trial. JAMA Surg. 2025 Aug 1;160(8):875-883. doi: 10.1001/jamasurg.2025.1987.

  PMID: 40601345 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Timothy Donahue, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a first-in-human, single-arm, open-label, dose-escalation phase I study to investigate the safety of Illuminare-1, a myelin-binding fluorescent small molecule in patients undergoing routine minimally invasive radical prostatectomy.

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: July 30, 2021
• Study Start: October 4, 2021
• Primary Completion: September 9, 2025
• Study Completion: September 9, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (6)