Evaluation of the Capability of the ¹³C-Octanoate Breath Test (OBT) Measurement in Patients With Chronic Liver Disease to Differentiate Between Presence and Absence of HCC Determined by MRI

HCC-BID-0411

The Exalenz clinical investigation is a multicenter, non-randomized, study of the ¹³C-Octanoate Breath Test (OBT). The present study is a feasibility trial, which aims to evaluate the capability of the OBT measurement to differentiate between presence and absence of HCC determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.

2011-11-01

2012-05-01

2013-05-01

Terminated

Early phase I

20

Inclusion Criteria: * Any patients with chronic liver disease at risk for HCC. * Age \> 18 years. * Patient has an MRI result (positive or negative for HCC) up to 3 months prior to recruitment or will be scheduled for an MRI during the trial period. * Patient is naïve to any HCC treatment. Exclusion Criteria: * Underwent any RFA or TACE or Oral HCC treatments. * Portal vein thrombosis. * Prior TIPS placement. * Severe congestive heart failure (LVEF on echocardiogram \< 20%). * Severe pulmonary hypertension (By echocardiogram, PAS \>45 mmHg). * Uncontrolled diabetes mellitus (HBA1C \>9.5%). * Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication. * Previous surgical bypass surgery for morbid obesity (BMI \>45). * Extensive small bowel resection. * Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs. * Women who are pregnant or breast feeding. * Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma. * Patient has taken drugs that can interfere with octanoate metabolism or can also cause NAFLD independent of the metabolic syndrome, including: corticosteroids, amiodarone, tetracycline, valproic acid, methotrexate, stavudine, zidovudine. * Patient, based on the opinion of the investigator, should not be enrolled into this study. * Patient is unable or unwilling to sign informed consent. * Patients that are participating in other clinical trials evaluating experimental treatments or procedures

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

2022-12-20