BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

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.

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Key information

Conditions

Chronic Liver Disease Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Soroka Medical Center, Beersheba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

c13 methacetin solution with breath analyzer

Device

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

Primary outcomes

Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS)

Time frame: Study day 1 after a 1 hour test

"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.

Secondary outcomes

AUC of ROC (Area Under Receiver Operating Characteristic Curve)

Time frame: At study day 1 after 1 hour test

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.

Sponsors and collaborators

Lead sponsor

Meridian Bioscience, Inc.

Industry

Registry information

Official study title

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

Acronym: MBT

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Aug 18, 2008
Registry last updated: Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed