Liver Function Assessment - Feasibility and Dosing Study

Hepatic Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02516319
• Other study ID #: LFA-0001
• Status: Terminated
• Phase: N/A
• First received: July 21, 2015
• Last updated: January 14, 2016
• Start date: September 2012
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Cardiox Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hepatic Failure
• Liver Failure

Intervention

Drug:
• ICG Dye

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cardiox Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse-event recording		Two hours post ICG dose	Yes
Other	Physical Examination		Up to one hour post ICG dose	Yes
Other	Blood pressure		Up to one hour post ICG dose	Yes
Other	Heart rate		Up to one hour post ICG dose	Yes
Other	Respiration		Up to one hour post ICG dose	Yes
Primary	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.	20 minutes post ICG dose	No
Secondary	ICG fluorescence detection at the scaphoid fossa of the ears		20 minutes post ICG dose	No
Secondary	Repeatability of the Cardiox LFA system to detect the ICG fluorescence in the same subjects over time.		20 minutes post ICG dose	No