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

NCT01433016 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-12-20

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Toronto General Hospital

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • Northwestern University

    collaborator OTHER

  • Henry Ford Health System

    collaborator OTHER

  • Hadassah Medical Organization

    collaborator OTHER

  • Meridian Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Morris Sherman, MD · Toronto General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-05-31
Completion
2013-05-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01433016 on ClinicalTrials.gov