drugset / Trial / NCT01433016
Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI
Phase 2
Terminated
20 enrolled
Meridian Bioscience, Inc.
Hadassah Medical Organization · collabHenry Ford Health System · collabMedical University of South Carolina · collabNorthwestern University · collabToronto General Hospital · collab
Non-randomizedSingle-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2011-11
- Primary completion
- 2012-05
- Completion
- 2013-05
Outcome
Outcome not reported
Stopped: “Due to budgetary issues, the company has decided to focus on other applications at this stage.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 13C Sodium Octanoate | Unknown | 100 mg | Oral |