BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

Meridian Bioscience, Inc.414 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

414

Conditions

Chronic Liver Disease

Interventions

c13 methacetin solution with breath analyzerDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Cedars Sinai Medical Center

Los Angeles, California, United States

Henry Ford Health Sytem

Detroit, Michigan, United States

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Study day 1 after a 1 hour test

Secondary Outcomes

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.

Time frame: At study day 1 after 1 hour test

Data from ClinicalTrials.gov

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