Fluorescent Imaging of Nerves With Illuminare-1 During Surgery

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04983862
Collaborator
Illuminare Biotechnologies (Other)
50
6
1
24
8.3
0.3

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Trial of Real-Time Intraoperative Fluorescent Imaging of Nerve Structures Using Illuminare-1, A Novel Myelin-Binding Fluorophore
Actual Study Start Date :
Oct 4, 2021
Anticipated Primary Completion Date :
Oct 4, 2023
Anticipated Study Completion Date :
Oct 4, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Illuminare-1

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT04983862
Other Study ID Numbers:
  • 21-099
First Posted:
Jul 30, 2021
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2022