Liver Function Assessment - Feasibility and Dosing Study

NCT ID: NCT02516319

Last Updated: 2016-01-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-01-31

Brief Summary

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.

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.

Conditions

Hepatic Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

ICG Dye

Intervention Type: DRUG

Liver Funtion Test Dye Detection Monitor

All cohorts receive continuous LFT monitoring post ICG injection.

Group Type: EXPERIMENTAL

ICG Dye

Intervention Type: DRUG

Interventions

ICG Dye

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cardiox Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael W Jopling, M.D

Role: PRINCIPAL_INVESTIGATOR

Cardiox Corporation

Other Identifiers

LFA-0001

Identifier Type: -

Identifier Source: org_study_id