Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Intraoperative Ureter Injury
• Intervention / Treatment: Drug: Nerindocianine for Injection

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Women & Infants Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;
  • Serum bilirubin ≥ 1.5 x IULN;
  • Aspartate transaminase (AST or serum glutamic oxaloacetic transaminase, SGOT) ≥ 2x IULN;• Alanine transaminase (ALT or serum glutamate pyruvate transaminase, SGPT) ≥ 2 x IULN.
• Females who are pregnant, lactating, or breastfeeding;
• Any other condition that, in the Investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Nerindocianine for Injection; Procedure: routine minimally invasive pelvic surgery.; Other Names: IRDye 800BK

What is the study measuring?

Primary 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 days
Dose response	Dose response based on the composite assessment of the anatomy and laterality for detection of pelvic ureter in women undergoing minimally invasive surgery	10 minutes through 90 minutes post administration

Collaborators and Investigators

• Sponsor: Li-Cor, Inc.
• Investigators: Principal Investigator: Kenneth H. Kim, M.D., University of Alabama at Birmingham

Publications and helpful links

General Publications

• Huh WK, Johnson JL, Elliott E, Boone JD, Leath CA 3rd, Kovar JL, Kim KH. Fluorescence Imaging of the Ureter in Minimally Invasive Pelvic Surgery. J Minim Invasive Gynecol. 2021 Feb;28(2):332-341.e14. doi: 10.1016/j.jmig.2020.06.022. Epub 2020 Jun 29.

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2017
• Primary Completion (Actual): November 19, 2018
• Study Completion (Actual): November 19, 2018

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: intraoperative monitoring; minimally invasive; intraoperative procedures; near infrared fluorescence; contrast agent; ureter imaging
• Other Study ID Numbers: LICOR-10417-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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