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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Intraoperative Ureter Injury
• Intervention / Treatment: Drug: Nerindocianine for injection

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center/Levine Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of ureter delineation using a Likert scale to measure ureter visualization	Evaluation of the pelvic ureter under WL and NIR illumination	Surgical procedure duration, estimated up to 5 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (ACTUAL): November 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: intraoperative monitoring; minimally invasive; intraoperative procedures; near infrared fluorescence; contrast agent
• Other Study ID Numbers: LICOR-10417-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No