Clinical trial NCT04636567: Open-label Study to Evaluate Nerindocianine as a Surgical Aid in Ureter Delineation During Minimally Invasive Surgery
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Intraoperative Ureter Injury
Keywords: contrast agent
intraoperative monitoring
intraoperative procedures
near infrared fluorescence
minimally invasive
Lead sponsor: Li-Cor, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of ureter delineation using a Likert scale to measure ureter visualization
timeFrame: Surgical procedure duration, estimated up to 5 hours
Secondary outcomes:
measure: Treatment-Emergent Adverse Events
timeFrame: 30 +/- 5 days
measure: Hourly time point scores concurrence with video review
timeFrame: Scoring occurs at 1-hour intervals for duration of surgical procedure (estimated duration from 1 to 5 hours)
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Charlotte
country: United States
facility: Carolinas Medical Center/Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Cleveland Clinic Florida
name: Giovanna Da Silva Southwich, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolinas Medical Center / Levine Cancer Institute
name: Jubilee Brown, M.D.
role: PRINCIPAL_INVESTIGATOR
References: