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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02516319

Enrollment

Registered

2015-08-05

Start date

2012-09-30

Completion date

2016-01-31

Last updated

2016-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Failure

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.

Interventions

DRUGICG Dye

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
ICG dye detection using the LFT system compared to serial blood sampling ethods.	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

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

Other

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026