← Back to Search

Fluorescent Nerve Imaging with Illuminare-1 for Prostate Cancer

Phase 1

Recruiting

Led By Timothy Donahue, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for minimally invasive radical prostatectomy with pelvic lymph node dissection

18 years or older and capable of signing their own consent form

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 45 days

Awards & highlights

Study Summary

This trial will test the safety of using a new drug, Illuminare-1, during surgery for prostate cancer. The researchers will test increasing doses of the drug to find the dose that makes the nerve structures fluoresce (light up) but causes few or mild side effects. If successful, this could improve the surgery and reduce side effects.

Who is the study for?

This trial is for adults over 18 who can consent and are scheduled for a specific prostate cancer surgery. It's not for those with prior pelvic procedures, recent investigational drugs use, significant kidney or liver issues, exposure to phototoxic drugs without proper washout period, or nervous system diseases.Check my eligibility

What is being tested?

The study tests Illuminare-1's safety and optimal dose during prostate cancer surgery. Researchers will see if surgeries guided by Illuminare-1 are better than standard ones and will also examine how the body processes this drug.See study design

What are the potential side effects?

Since this is the first test of Illuminare-1 in humans, potential side effects include reactions at different doses that could range from mild to severe; specifics will be determined as the trial progresses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a specific prostate surgery with lymph node removal.

Select...

I am over 18 and can sign a consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 45 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 45 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 45 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

determine the safety of Illuminare-1

Trial Design

1Treatment groups

Experimental Treatment

Group I: Illuminare-1Experimental Treatment2 Interventions

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,839 Total Patients Enrolled

Illuminare BiotechnologiesUNKNOWN

Timothy Donahue, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Illuminare-1 Clinical Trial Eligibility Overview. Trial Name: NCT04983862 — Phase 1

Prostate Adenocarcinoma Research Study Groups: Illuminare-1

Prostate Adenocarcinoma Clinical Trial 2023: Illuminare-1 Highlights & Side Effects. Trial Name: NCT04983862 — Phase 1

Illuminare-1 2023 Treatment Timeline for Medical Study. Trial Name: NCT04983862 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research program currently recruiting volunteers?

"Yes, the records available on clinicaltrials.gov verify that this experiment is actively enrolling participants with a posting date of October 4th 2021 and an update issued September 30th 2022."

Answered by AI

How much security can be expected from the Illuminare-1 system?

"Due to the lack of safety data, Illuminare-1 was assigned a score of 1 on our risk assessment scale. This is because this trial is currently in Phase 1 and therefore has limited evidence regarding both safety and efficacy."

Answered by AI

How many facilities are offering this trial as an option?

"Six distinct clinical trial sites are participating, including Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities) in Commack, Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale and Memorial Sloan Kettering Westchester (Limited protocol activities) in Harrison. There also 3 other locations that have joined the study."

Answered by AI

What is the magnitude of participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov's records display that this research is actively recruiting, with the first posting having occured on October 4th 2021 and latest update happening September 30th 2022. A total of 50 participants must be recruited across 6 sites in order to complete the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fluorescent Imaging of Nerves With Illuminare-1 During Surgery

2021. "Fluorescent Imaging of Nerves With Illuminare-1 During Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04983862.