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

Primary Purpose

Chronic Liver Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
c13 methacetin solution with breath analyzer
Sponsored by
Meridian Bioscience, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Liver Disease focused on measuring Methacetin, Breath, Test, Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars Sinai Medical Center
  • Henry Ford Health Sytem
  • Cleveland Clinic
  • University of Pennsylvania Health System
  • Medical University of South Carolina
  • St Luke's Episcopal Hospital, Baylor College of Medicine
  • Inova Helath System
  • Virginia Commonwealth University Medical Center
  • Soroka Medical Center
  • Carmel Medical Center
  • Hadassah Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CLD (chronic liver disease)

Arm Description

Chronic liver disease subjects with recent biopsy will be tested with a breath tests using a 13C enriched substrate metabolized by their liver

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 14, 2008
Last Updated
December 19, 2022
Sponsor
Meridian Bioscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00736840
Brief Title
BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis
Acronym
MBT
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 Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meridian Bioscience, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease
Keywords
Methacetin, Breath, Test, Cirrhosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
414 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CLD (chronic liver disease)
Arm Type
Other
Arm Description
Chronic liver disease subjects with recent biopsy will be tested with a breath tests using a 13C enriched substrate metabolized by their liver
Intervention Type
Device
Intervention Name(s)
c13 methacetin solution with breath analyzer
Intervention Description
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 Measure Information:
Title
Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS)
Description
"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 Outcome Measure Information:
Title
AUC of ROC (Area Under Receiver Operating Characteristic Curve)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Gordon, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adrian Rueben, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gadi Lalazar, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arun Sanyal, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fred Poordad, MD
Organizational Affiliation
Cedars Sinai Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
K Rajender Reddy, MD
Organizational Affiliation
University of Pennsylvania Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zobair Younossi, MD
Organizational Affiliation
Inova Health Care Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arthur McCullough, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Vierling, MD
Organizational Affiliation
St. Luke's Episcopal Hospital, Baylor College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Fich, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eli Zuckerman, MD
Organizational Affiliation
Carmel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Henry Ford Health Sytem
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29435
Country
United States
Facility Name
St Luke's Episcopal Hospital, Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Inova Helath System
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0341
Country
United States
Facility Name
Soroka Medical Center
City
Beer Sheba
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
93000
Country
Israel

12. IPD Sharing Statement

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