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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00736840
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : March 16, 2012
Last Update Posted : March 16, 2012
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Liver Disease Device: c13 methacetin solution with breath analyzer Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 414 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Pivotal Study to Evaluate the Efficacy and Safety of the BreathID® System for Detection of Cirrhosis Using the ¹³C-methacetin Breath Test(MBT)
Study Start Date : August 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00736840

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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Michigan
Henry Ford Health Sytem
Detroit, Michigan, United States, 48202
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29435
United States, Texas
St Luke's Episcopal Hospital, Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Inova Helath System
Falls Church, Virginia, United States, 22042
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298-0341
Soroka Medical Center
Beer Sheba, Israel
Carmel Medical Center
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel, 93000
Sponsors and Collaborators
Exalenz Bioscience LTD.
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Principal Investigator: Stuart Gordon, MD Henry Ford Health System
Principal Investigator: Adrian Rueben, MD Medical University of South Carolina
Principal Investigator: Gadi Lalazar, MD Hadassah Medical Center
Principal Investigator: Arun Sanyal, MD Virginia Commonwealth University
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 System
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
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Responsible Party: Exalenz Bioscience LTD. Identifier: NCT00736840    
Other Study ID Numbers: HIS-EX-408
First Posted: August 18, 2008    Key Record Dates
Results First Posted: March 16, 2012
Last Update Posted: March 16, 2012
Last Verified: February 2012
Keywords provided by Exalenz Bioscience LTD.:
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Pathologic Processes
Digestive System Diseases