NCT01433016

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-05-01
• Completion: 2013-05-01
• First posted: 2011-09-13
• Last updated: 2022-12-20
• Results posted: 2014-04-07

Locations

1 site across 1 country: Canada