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Liver Function Assessment - Feasibility and Dosing Study

Primary Purpose

Hepatic Failure

Status

Terminated

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

ICG Dye

About this trial

This is an interventional diagnostic trial for Hepatic Failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Serial Blood Draws

Liver Funtion Test Dye Detection Monitor

Arm Description

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.

All cohorts receive continuous LFT monitoring post ICG injection.

Outcomes

Primary Outcome Measures

ICG dye detection using the LFT system compared to serial blood sampling ethods.

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 Outcome Measures

ICG fluorescence detection at the scaphoid fossa of the ears

Repeatability of the Cardiox LFA system to detect the ICG fluorescence in the same subjects over time.

Full Information

NCT ID

NCT02516319

First Posted

July 21, 2015

Last Updated

January 14, 2016

Sponsor

Cardiox Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02516319

Brief Title

Liver Function Assessment - Feasibility and Dosing Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Terminated

Why Stopped

Business decision to discontinue product development.

Study Start Date

September 2012 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cardiox Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Failure

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Serial Blood Draws

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Liver Funtion Test Dye Detection Monitor

Arm Type

Experimental

Arm Description

All cohorts receive continuous LFT monitoring post ICG injection.

Intervention Type

Drug

Intervention Name(s)

ICG Dye

Primary Outcome Measure Information:

Title

ICG dye detection using the LFT system compared to serial blood sampling ethods.

Description

Determination of an adequate dose for the Cardiox Liver Functioning Assessment LFA system to produce liver function assessments consistent with serial blood sampling methods.

Time Frame

20 minutes post ICG dose

Secondary Outcome Measure Information:

Title

ICG fluorescence detection at the scaphoid fossa of the ears

Time Frame

20 minutes post ICG dose

Title

Repeatability of the Cardiox LFA system to detect the ICG fluorescence in the same subjects over time.

Time Frame

20 minutes post ICG dose

Other Pre-specified Outcome Measures:

Title

Adverse-event recording

Time Frame

Two hours post ICG dose

Title

Physical Examination

Time Frame

Up to one hour post ICG dose

Title

Blood pressure

Time Frame

Up to one hour post ICG dose

Title

Heart rate

Time Frame

Up to one hour post ICG dose

Title

Respiration

Time Frame

Up to one hour post ICG dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael W Jopling, M.D

Organizational Affiliation

Cardiox Corporation

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Liver Function Assessment - Feasibility and Dosing Study

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