Liver Function Assessment – Feasibility and Dosing Study

Overview

The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an adequate dose based on LFA technology and 3) determine an adequate time period for LFA determination.

Full Title of Study: “A Feasibility Study to Determine an Adequate Dose of ICG for the Liver Function Assessment System in Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

Detailed Description

Four cohorts of subjects will be enrolled. The fist two cohorts will receive fixed doses of ICG dye (2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg) followed by 20 minutes of LFT monitoring. The final two cohorts will receive weight based doses of ICG dye (0.1 mg/kg, 0.5 mg/kg) followed by 20 minutes of LFT monitoring. Additionally the final two cohorts will have serial blood draws before the ICG dose and at 5, 10, 15 and 20 minutes post ICG dose.

Interventions

  • Drug: ICG Dye

Arms, Groups and Cohorts

  • Active Comparator: Serial Blood Draws
    • Cohorts 3 and 4 – weight based doses of ICG dye followed by serial blood draws at 5, 10, 15 and 20 minutes post ICG injection.
  • Experimental: Liver Funtion Test Dye Detection Monitor
    • All cohorts receive continuous LFT monitoring post ICG injection.

Clinical Trial Outcome Measures

Primary Measures

  • ICG dye detection using the LFT system compared to serial blood sampling ethods.
    • Time Frame: 20 minutes post ICG dose
    • Determination of an adequate dose for the Cardiox Liver Functioning Assessment LFA system to produce liver function assessments consistent with serial blood sampling methods.

Secondary Measures

  • ICG fluorescence detection at the scaphoid fossa of the ears
    • Time Frame: 20 minutes post ICG dose
  • Repeatability of the Cardiox LFA system to detect the ICG fluorescence in the same subjects over time.
    • Time Frame: 20 minutes post ICG dose

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female subjects, aged 18 to 75 years, inclusive – Informed consent documentation understood and signed. Exclusion Criteria:

  • Known allergy or sensitivity to the ICG or to iodide contrast dye – Pregnant women or those nursing babies

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cardiox Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael W Jopling, M.D, Principal Investigator, Cardiox Corporation

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