Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI
Condition: Chronic Liver Disease; Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Diseases
Intervention: 13C Sodium Octanoate
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCC Hepatocellular carcinoma; OBT Octanoate Breath Test

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.
    

Eligibility criteria:

        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