BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis (MBT)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Liver Disease
• Intervention / Treatment: Device: c13 methacetin solution with breath analyzer

Detailed Description

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
• Enrollment (Actual): 414
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Beer Sheba, Israel
    • Soroka Medical Center
  • Haifa, Israel
    • Carmel Medical Center
  • Jerusalem, Israel, 93000
    • Hadassah Medical Center
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health Sytem
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
  • South Carolina
    • Charleston, South Carolina, United States, 29435
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • St Luke's Episcopal Hospital, Baylor College of Medicine
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Helath System
    • Richmond, Virginia, United States, 23298-0341
      • Virginia Commonwealth University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CLD (chronic liver disease); 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Meridian Bioscience, Inc.
• Investigators: Principal Investigator: Arun Sanyal, MD, Virginia Commonwealth University; Principal Investigator: Stuart Gordon, MD, Henry Ford Health System; Principal Investigator: Adrian Rueben, MD, Medical University of South Carolina; Principal Investigator: Fred Poordad, MD, Cedars Sinai Health System; Principal Investigator: K Rajender Reddy, MD, University of Pennsylvania Health System; Principal Investigator: Zobair Younossi, MD, Inova Health Care Services; Principal Investigator: Arthur McCullough, MD, The Cleveland Clinic; Principal Investigator: John Vierling, MD, St. Luke's Episcopal Hospital, Baylor College of Medicine; Principal Investigator: Alexander Fich, MD, Soroka University Medical Center; Principal Investigator: Eli Zuckerman, MD, Carmel Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: August 14, 2008
• First Submitted That Met QC Criteria: August 15, 2008
• First Posted (Estimate): August 18, 2008

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Cirrhosis; Test; Breath; Methacetin
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis
• Other Study ID Numbers: HIS-EX-408