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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.
At study day one after one hour
Morris Sherman, MD
Toronto General Hospital
United States: Food and Drug Administration