- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02516319
Liver Function Assessment - Feasibility and Dosing Study
January 14, 2016 updated by: Cardiox Corporation
A Feasibility Study to Determine an Adequate Dose of ICG for the Liver Function Assessment System in Healthy Volunteers
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
|
Experimental: Liver Funtion Test Dye Detection Monitor
All cohorts receive continuous LFT monitoring post ICG injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICG dye detection using the LFT system compared to serial blood sampling ethods.
Time Frame: 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.
|
20 minutes post ICG dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ICG fluorescence detection at the scaphoid fossa of the ears
Time Frame: 20 minutes post ICG dose
|
20 minutes post ICG dose
|
Repeatability of the Cardiox LFA system to detect the ICG fluorescence in the same subjects over time.
Time Frame: 20 minutes post ICG dose
|
20 minutes post ICG dose
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse-event recording
Time Frame: Two hours post ICG dose
|
Two hours post ICG dose
|
Physical Examination
Time Frame: Up to one hour post ICG dose
|
Up to one hour post ICG dose
|
Blood pressure
Time Frame: Up to one hour post ICG dose
|
Up to one hour post ICG dose
|
Heart rate
Time Frame: Up to one hour post ICG dose
|
Up to one hour post ICG dose
|
Respiration
Time Frame: Up to one hour post ICG dose
|
Up to one hour post ICG dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael W Jopling, M.D, Cardiox Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
July 21, 2015
First Submitted That Met QC Criteria
August 4, 2015
First Posted (Estimate)
August 5, 2015
Study Record Updates
Last Update Posted (Estimate)
January 15, 2016
Last Update Submitted That Met QC Criteria
January 14, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LFA-0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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