NCT02415283

OBT Measurement to Differentiate Between Presence and Absence of HCC Determined by MRI

Evaluation of the Capability of the ¹³C-Octanoate Breath Test (OBT) Measurement to Differentiate Between Presence and Absence of HCC Determined by MRI in Patients With Chronic Liver Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2 (estimated)
• Sponsor: Beijing 302 Hospital · Academic / Other
• 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 to differentiate between presence and absence of HCC determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.

Detailed description

1. Informed consent will be obtained from all patients prior to enrollment. 2. The trial will be conducted in compliance with this protocol, with GCP standards, and the applicable regulatory requirements. 3. This study will be cross-sectional, where patients will be enrolled on a walk in basis. Once one arm is completed the other one will be enriched in order to obtain at least 50 positive and at least 50 negative HCC subjects as defined by MRI. 4. All patients will undergo AFP and US if they do not have results within the past three months. 5. If the patient undergoes liver FNA, the biopsy results will be evaluated for the presence of HCC. 6. For all patients, a case report form will be completed. 7. All patients will undergo a physical examination, and their medical history/concomitant medications, weight, height and age will be recorded. Furthermore, recent (past 3 months) blood test results, if available, may be recorded. 8. If relevant (woman of child bearing age), a pregnancy test will be performed to rule out pregnancy when performing the breath test. 9. All MRI negative patients with low OBT results will undergo additional MRI within 6 to 12 months post OBT to rule out HCC occurrence. 10. If available, all additional MRI/CT/US results will be recorded within the patient's CRF.

Conditions

• HCC

Interventions

Type	Name	Description
DEVICE	¹³C-Octanoate Breath Test	Breath testing utilizing 13C is a safe, non-invasive means for measuring a certain pathway's metabolic rate. 13C is a stable, non-radioactive isotope which can be incorporated into a specific location within a test substrate so it would be released when the compound is metabolized by the liver. Hepatic metabolism of the compound is assessed by measuring the ratio of 13CO2/12CO2 in exhaled breath.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-03-01
• Completion: 2016-12-01
• First posted: 2015-04-14
• Last updated: 2015-04-14