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COMPLETED Phase 1

Fluorescent Imaging of Nerves With Illuminare-1 During Surgery

NCT04983862 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 41 participants
Start Date 2021-10-04
Est. Completion 2025-09-09
Phase Phase 1

Sponsor

Memorial Sloan Kettering Cancer Center

2,280 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04983862

The ClinicalTrials.gov registry entry for NCT04983862 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 2,280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04983862 reports 6 study locations spanning 2 distinct geographic areas — top geographies include New Jersey, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04983862?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 2,280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial