BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

Phase 3

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
CLD (chronic liver disease)	c13 methacetin solution with breath analyzer	Chronic liver disease subjects with recent biopsy will be tested with a breath tests using a 13C enriched substrate metabolized by their liver

Primary Outcome Measures

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

Name	Time	Method
AUC of ROC (Area Under Receiver Operating Characteristic Curve)	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.

Locations (11): Carmel Medical Center
🇮🇱
Haifa, Israel
Soroka Medical Center
🇮🇱
Beer Sheba, Israel
Hadassah Medical Center
🇮🇱
Jerusalem, Israel
Inova Helath System
🇺🇸
Falls Church, Virginia, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Cedars Sinai Medical Center
🇺🇸
Los Angeles, California, United States
University of Pennsylvania Health System
🇺🇸
Philadelphia, Pennsylvania, United States
St Luke's Episcopal Hospital, Baylor College of Medicine
🇺🇸
Houston, Texas, United States
Henry Ford Health Sytem
🇺🇸
Detroit, Michigan, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Virginia Commonwealth University Medical Center
🇺🇸
Richmond, Virginia, United States