A Phase I/IIa Dose-escalation Study to Evaluate the Use of an Investigational Imaging Agent for the Detection of Urologic Anatomy Via Near Infrared Fluorescence Imaging in the Setting of Minimally Invasive Surgery

Li-Cor, Inc.1 site in 1 country41 target enrollmentApril 26, 2017

ConditionsIntraoperative Ureter Injury

InterventionsNerindocianine for Injection

DrugsNerindocianine for Injection

Overview

Phase: Phase 1
Intervention: Nerindocianine for Injection
Conditions: Intraoperative Ureter Injury
Sponsor: Li-Cor, Inc.
Enrollment: 41
Locations: 1
Primary Endpoint: Treatment-Emergent Adverse Events
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.

Registry

clinicaltrials.gov

Start Date

April 26, 2017

End Date

November 19, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Sequential

Sex

Female

Investigators

Sponsor

Li-Cor, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provide written informed consent prior to the initiation of study procedures
•Are \> 18 years of age
•Women consented to undergo standard of care minimally invasive pelvic surgery (traditional laparoscopy and robotic surgery)
•Women who are expected to be admitted to the hospital following surgery for at least 24 hours

Exclusion Criteria

•Are unwilling or unable to provide informed consent.
•Are unwilling or unable to comply with the requirements of the protocol.
•History of prior urologic surgery.
•History of prior pelvic surgery.
•History of known retroperitoneal fibrosis.
•Have any of the following screening laboratory values:
•Hemoglobin ≤ 8.0 g/dL;
•Absolute neutrophil count (ANC) ≤ 1500/μL;
•Platelet count ≤ 100,000/μL;
•Serum creatinine ≥ 1.5 x the institutional upper limit of normal (IULN) creatinine;

Arms & Interventions

Nerindocianine for Injection

One Arm: Nerindocianine for Injection (Initial dosing cohort: 0.06 mg/kg body weight); solution, intravenous, one time administration during surgery. the study has only one arm.

Intervention: Nerindocianine for Injection

Outcomes

Primary Outcomes

Treatment-Emergent Adverse Events

Time Frame: 30 days

Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events

Dose response

Time Frame: 10 minutes through 90 minutes post administration

Dose response based on the composite assessment of the anatomy and laterality for detection of pelvic ureter in women undergoing minimally invasive surgery