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Fluorescent Imaging of Nerves With Illuminare-1 During Surgery

Primary Purpose

Prostate Adenocarcinoma

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Illuminare-1

Karl Storz D-Light C photodynamic diagnostic (PDD)

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Fluorescent Imaging, Illuminare-1, Myelin-Binding Fluorophore, 21-099

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
Memorial Sloan Kettering Monmouth (Limited protocol activities)Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities)Recruiting
Memorial Sloan Kettering Westchester (Limited protocol activities)Recruiting
Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Illuminare-1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04983862

First Posted

July 22, 2021

Last Updated

October 20, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Illuminare Biotechnologies

1. Study Identification

Unique Protocol Identification Number

NCT04983862

Brief Title

Fluorescent Imaging of Nerves With Illuminare-1 During Surgery

Official Title

Phase I Trial of Real-Time Intraoperative Fluorescent Imaging of Nerve Structures Using Illuminare-1, A Novel Myelin-Binding Fluorophore

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 4, 2021 (Actual)

Primary Completion Date

October 4, 2025 (Anticipated)

Study Completion Date

October 4, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Illuminare Biotechnologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Adenocarcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Illuminare-1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Illuminare-1

Intervention Description

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 0.5 mg/kg until a maximum dose of 2.25mg/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.

Intervention Type

Device

Intervention Name(s)

Karl Storz D-Light C photodynamic diagnostic (PDD)

Intervention Description

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

Primary Outcome Measure Information:

Title

determine the safety of Illuminare-1

Description

Time Frame

up to 45 days

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Prostate cancer

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Timothy Donahue, MD

Phone

646-422-4567

donahuet@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Vincent Laudone, MD

Phone

646-888-7087

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy Donahue, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

City

Basking Ridge

State/Province

New Jersey

ZIP/Postal Code

07920

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timothy Donahue, MD

Phone

646-422-4567

Facility Name

Memorial Sloan Kettering Monmouth (Limited protocol activities)

City

Middletown

State/Province

New Jersey

ZIP/Postal Code

07748

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timothy Donahue, MD

Phone

646-422-4567

Facility Name

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

City

Montvale

State/Province

New Jersey

ZIP/Postal Code

07645

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timothy Donahue, MD

Phone

646-422-4567

Facility Name

Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities)

City

Commack

State/Province

New York

ZIP/Postal Code

11725

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timothy Donahue, MD

Phone

646-422-4567

Facility Name

Memorial Sloan Kettering Westchester (Limited protocol activities)

City

Harrison

State/Province

New York

ZIP/Postal Code

10604

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timothy Donahue, MD

Phone

646-422-4567

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timothy Donahue, MD

Phone

646-422-4567

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

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Fluorescent Imaging of Nerves With Illuminare-1 During Surgery

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