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
18 Years
N/A
Both
Chronic Liver Disease, Hepatocellular Carcinoma (HCC)
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
PDR peak
Outcome Description:
PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.
Outcome Time Frame:
At study day one after one hour
Safety Issue:
No
Principal Investigator
Morris Sherman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Toronto General Hospital
Authority:
United States: Food and Drug Administration
Study ID:
HCC-BID-0411
NCT ID:
NCT01433016
Start Date:
November 2011
Completion Date:
September 2012
Related Keywords:
- Chronic Liver Disease
- Hepatocellular Carcinoma (HCC)
- HCC Hepatocellular carcinoma
- OBT Octanoate Breath Test
- Carcinoma
- Liver Diseases
- Carcinoma, Hepatocellular
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