BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

Study Overview
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Brief Summary
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This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.

Detailed Description
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Patients with chronic liver disease who have a recent biopsy will be offered a breath test. Correlation will be shown between histology and breath test in determining cirrhosis.

Official Title
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Pivotal Study to Evaluate the Efficacy and Safety of the BreathID® System for Detection of Cirrhosis Using the ¹³C-methacetin Breath Test(MBT)

Conditions
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Chronic Liver Disease

Intervention / Treatment
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* Device: c13 methacetin solution with breath analyzer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 with chronic liver disease Exclusion Criteria: Patients that are taking hepatotoxin drug. Patient with severe congestive heart failure Patient with severe pulmonary hypertension Patient with uncontrolled diabetes mellitus Patient with previous surgical bypass surgery for morbid obesity Patient with extensive small bowel resection Patient currently receiving total parenteral nutrition Patient is a recipients of any organ transplant Patients that received any anti-viral treatment within the past year Women who are pregnant Patient allergic to acetaminophen (such as Tylenol or any other related medications) Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma Patients unable to sign informed consent Patients that based on the opinion of the investigator should not be enrolled into this study Patients that are participating in other clinical trials evaluating experimental treatments or procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CLD (chronic liver disease)<br>Chronic liver disease subjects with recent biopsy will be tested with a breath tests using a 13C enriched substrate metabolized by their liver | Device: c13 methacetin solution with breath analyzer<br>* Carbon 13 methacetin 75mg dissolved in 150 ml is given to the subject and metabolism is measured by a breath analyzer after decomposed by the liver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Likelihood of Cirrhosis Based on Hepatic Impairment Score (HIS) | Hepatic Impairment Score (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy result of cirrhosis detection as the gold standard. | Study day 1 after a 1 hour test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of ROC (Area Under Receiver Operating Characteristic Curve) | The AUC represents a summary measure of the ROC curve and is the accuracy of the HIS in detecting cirrhosis compared to the gold standard of biopsy. | At study day 1 after 1 hour test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhosis, Methacetin, Breath, Test