Liver Function Assessment - Feasibility and Dosing Study

January 14, 2016 updated by: Cardiox Corporation

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 minutes post ICG dose

Secondary Outcome Measures

Outcome Measure
Time Frame
ICG fluorescence detection at the scaphoid fossa of the ears
Time Frame: 20 minutes post ICG dose
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
20 minutes post ICG dose

Other Outcome Measures

Outcome Measure
Time Frame
Adverse-event recording
Time Frame: Two hours post ICG dose
Two hours post ICG dose
Physical Examination
Time Frame: Up to one hour post ICG dose
Up to one hour post ICG dose
Blood pressure
Time Frame: Up to one hour post ICG dose
Up to one hour post ICG dose
Heart rate
Time Frame: Up to one hour post ICG dose
Up to one hour post ICG dose
Respiration
Time Frame: Up to one hour post ICG dose
Up to one hour post ICG dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael W Jopling, M.D, Cardiox Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 21, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 5, 2015

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • LFA-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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