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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03106038
Recruitment Status : Completed
First Posted : April 10, 2017
Last Update Posted : November 26, 2019
Information provided by (Responsible Party):
Li-Cor, Inc.

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.

Condition or disease Intervention/treatment Phase
Intraoperative Ureter Injury Drug: Nerindocianine for Injection Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Sequential Assignment
Intervention Model Description: beginning at the estimated target dose, the dosage was increased and decreased to confirm the near-optimal dose.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : April 26, 2017
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : November 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy

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 Name: IRDye 800BK

Primary Outcome Measures :
  1. Treatment-Emergent Adverse Events [ Time Frame: 30 days ]
    Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03106038

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United States, Alabama
UAB Women & Infants Center
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
Li-Cor, Inc.
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Principal Investigator: Kenneth H. Kim, M.D. University of Alabama at Birmingham
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Li-Cor, Inc. Identifier: NCT03106038    
Other Study ID Numbers: LICOR-10417-01
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li-Cor, Inc.:
contrast agent
ureter imaging
intraoperative monitoring
intraoperative procedures
near infrared fluorescence
minimally invasive