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NCT04983862 · ClinicalTrials.gov registry record · Phase 1
Fluorescent Imaging of Nerves With Illuminare-1 During Surgery
A Phase 1 study of Prostate Adenocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 6
- Study locations
NCT04983862: Completed Phase 1 study of Prostate Adenocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04983862 is a Phase 1 study of Prostate Adenocarcinoma that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 41 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (81% lower). The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04983862, a Phase 1 study of Prostate Adenocarcinoma, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Illuminare-1
- DEVICE Karl Storz D-Light C photodynamic diagnostic (PDD)
Study Locations (6)
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited protocol activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
New York
- Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited protocol activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2021-10-04 |
| Est. Completion | 2025-09-09 |
| Phase | Phase 1 |
What the finished NCT04983862 record still lists
NCT04983862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Illuminare-1 is the first listed.
NCT04983862 lists 6 locations in 2 states (New Jersey, New York).
Frequently Asked Questions
What is clinical trial NCT04983862 about?
NCT04983862 is a clinical study titled "Fluorescent Imaging of Nerves With Illuminare-1 During Surgery". 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 thi...
What is the current status of trial NCT04983862?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2021-10-04. Estimated completion is 2025-09-09.
What conditions does trial NCT04983862 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma.
What interventions are being tested in trial NCT04983862?
The interventions under investigation include: Illuminare-1 (DRUG), Karl Storz D-Light C photodynamic diagnostic (PDD) (DEVICE).
Who is sponsoring clinical trial NCT04983862?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04983862 being conducted?
This trial has 6 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04983862's enrollment target sits among peer trials
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