Liver Function Assessment - Feasibility and Dosing Study
Primary Purpose
Hepatic Failure
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ICG Dye
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatic Failure
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
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
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
No
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
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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