Chronic Liver Disease, Hepatocellular Carcinoma (HCC)
Conditions
Keywords
HCC Hepatocellular carcinoma, OBT Octanoate Breath Test
Brief summary
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.
Detailed description
The Octanoate Breath Test (OBT) developed by Exalenz is performed by the BreathID System consists of the BreathID device and a test kit containing a nasal cannula, a calibration gas container and a non-radioactive isotope ¹³C- Octanoate solution, and measures and computes the ratio between ¹³CO2 and 12CO2 in the patient's exhaled breath. This study's aim is to provide data on this novel system to dynamically and accurately assess liver function at the bed side. It is hoped that the system will provide prognostic information faster than is achieved at present with traditional methods. It is hypothesized that in the future the OBT may have an impact on decision making and clinical practice in this group of HCC patients, allowing a greater chance for proper management and hence survival.
Interventions
DRUG13C Sodium Octanoate
13C labeled Sodium Octanoate Substrate is provided in powder form in doses of 100mg for single breath test, and is dissolved in 150cc of tap water before ingestion. Duration of the observation after the drug ingestion is one hour.
Sponsors
Toronto General Hospital
Medical University of South Carolina
Northwestern University
Henry Ford Health System
Hadassah Medical Organization
Meridian Bioscience, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PDR Peak | At study day one after one hour | PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Suspected HCC Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Suspected HCC |
|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment Israel | 20 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
PDR Peak
PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.
Time frame: At study day one after one hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suspected HCC | PDR Peak | 23.78 percentage of dose recovery | Standard Deviation 5.51 |