Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI (OBT for HCC)
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.
Chronic Liver Disease
Hepatocellular Carcinoma (HCC)
Drug: 13C Sodium Octanoate
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||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|
- PDR Peak [ Time Frame: At study day one after one hour ] [ Designated as safety issue: No ]PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.
|Study Start Date:||November 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Octanaote Breath Test
A Octanoate breath test will be performed on this single arm population
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433016
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2N2|
|Principal Investigator:||Morris Sherman, MD||Toronto General Hospital|