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

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ClinicalTrials.gov Identifier: NCT03106038
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : November 17, 2017
Sponsor:
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: Investigational Imaging Agent Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
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 : May 4, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Investigational Imaging Agent
One Arm: Investigational Imaging Agent (Initial dosing cohort: 0.06 mg/kg body weight), solution, intravenous, one time administration during surgery.
Drug: Investigational Imaging Agent
Procedure: routine minimally invasive pelvic surgery.




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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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;
    • 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 ClinicalTrials.gov identifier (NCT number): NCT03106038


Contacts
Contact: Stuart Byham 919-741-5266 sbyham@medsource.com
Contact: Bambi Reynolds 402-467-0752 bambi.reynolds@licor.com

Locations
United States, Alabama
UAB Women & Infants Center Recruiting
Birmingham, Alabama, United States, 35233
Contact: Kenneth H Kim, MD         
Sponsors and Collaborators
Li-Cor, Inc.
Investigators
Principal Investigator: Kenneth H. Kim, M.D. University of Alabama at Birmingham

Responsible Party: Li-Cor, Inc.
ClinicalTrials.gov Identifier: NCT03106038     History of Changes
Other Study ID Numbers: LICOR-10417-01
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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