Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI

NCT ID: NCT01433016

Last Updated: 2022-12-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-05-31

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.

Conditions

Chronic Liver Disease; Hepatocellular Carcinoma (HCC)

Keywords

HCC Hepatocellular carcinoma; OBT Octanoate Breath Test

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Octanaote Breath Test

A Octanoate breath test will be performed on this single arm population

Group Type: EXPERIMENTAL

13C Sodium Octanoate

Intervention Type: DRUG

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.

Interventions

13C 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Toronto General Hospital

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

Henry Ford Health System

OTHER

Sponsor Role: collaborator

Hadassah Medical Organization

OTHER

Sponsor Role: collaborator

Meridian Bioscience, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Morris Sherman, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital

Locations

Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

HCC-BID-0411

Identifier Type: -

Identifier Source: org_study_id