Trial | NCT02516319  Report issue

Title

Liver Function Assessment - Feasibility and Dosing Study
A Feasibility Study to Determine an Adequate Dose of ICG for the Liver Function Assessment System in Healthy Volunteers

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    57
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.
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.
Study Started
Sep 30
2012
Primary Completion
Jan 31
2016
Study Completion
Jan 31
2016
Last Update
Jan 15
2016
Estimate

Drug ICG Dye

Serial Blood Draws Active Comparator

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.

Liver Funtion Test Dye Detection Monitor Experimental

All cohorts receive continuous LFT monitoring post ICG injection.

Criteria 

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
No Results Posted