Open-label Study to Evaluate Nerindocianine as a Surgical Aid in Ureter Delineation During Minimally Invasive Surgery

Sponsor

Li-Cor, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04636567

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase 2, multicenter, efficacy and safety study evaluating the use of nerindocianine for the delineation of abdominopelvic ureter anatomy via near infrared fluorescence imaging during minimally invasive lower abdominal surgery (e.g. gynecological, lower gastrointestinal, or other lower abdominal surgery).

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Ureter Injury	Drug: Nerindocianine for injection	Phase 2

Detailed Description

The primary objective of this study is to assess the acceptance of near-infrared (NIR) fluorescence imaging (650 to 900 nm) compared to white light (WL) using 3 3-point Likert scales.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

A Phase 2 Open-label Study to Evaluate the Use of Nerindocianine as a Surgical Aid in the Delineation of Abdominopelvic Ureter Anatomy Via Near-infrared Fluorescence Imaging in the Setting of Minimally Invasive Surgery

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nerindocianine for injection One Arm: Nerindocianine for Injection (0.055 mg/kg body weight); solution, intravenous, one time administration during surgery.	Drug: Nerindocianine for injection Procedure: routine minimally invasive abdominopelvic surgery. Other Names: IRDye 800BK

Arm

Intervention/Treatment

Experimental: Nerindocianine for injection

One Arm: Nerindocianine for Injection (0.055 mg/kg body weight); solution, intravenous, one time administration during surgery.

Drug: Nerindocianine for injection

Procedure: routine minimally invasive abdominopelvic surgery.

Other Names:

IRDye 800BK

Outcome Measures

Primary Outcome Measures

Evaluation of ureter delineation using a Likert scale to measure ureter visualization [Surgical procedure duration, estimated up to 5 hours]
Evaluation of the pelvic ureter under WL and NIR illumination

Secondary Outcome Measures

Treatment-Emergent Adverse Events [30 +/- 5 days]
Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events
Hourly time point scores concurrence with video review [Scoring occurs at 1-hour intervals for duration of surgical procedure (estimated duration from 1 to 5 hours)]
Three 3-pt Likert scale scores at hourly time points during the procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Provide written informed consent prior to the initiation of study procedures.
At least 18 years of age.
Consent to undergo minimally invasive, lower pelvic surgery.

Exclusion Criteria:

Unwilling or unable to provide informed consent.
Unwilling or unable to comply with the requirements of the protocol.
Females who are pregnant, lactating, or planning a pregnancy throughout the study.
Patients administered indocyanine green (ICG) at the same time of the lower pelvic surgery.
Have known allergies to D-mannitol and/or citric acid.
Participation in another clinical trial involving a drug in the past 12 weeks.
Any other condition that, in the investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy of the investigational product, or determined not a safe candidate for surgery based on standard of care for current medical condition.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Florida	Weston	Florida	United States	33331
2	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina	United States	28204

Sponsors and Collaborators

Li-Cor, Inc.

Investigators

Principal Investigator: Giovanna Da Silva Southwich, M.D., Cleveland Clinic Florida
Principal Investigator: Jubilee Brown, M.D., Carolinas Medical Center / Levine Cancer Institute