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

Phase 2

Withdrawn

• Conditions: Intraoperative Ureter Injury
• Interventions: Drug: Nerindocianine for injection

• Registration Number: NCT04636567
• Lead Sponsor: Li-Cor, Inc.

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).

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 Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-19
• Study Start: 2021-03
• Last Update Submitted: 2021-06-30
• Primary Completion: 2021-07
• Last Update Posted: 2021-07-02
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States

Carolinas Medical Center/Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States