Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis

December 19, 2022 updated by: Meridian Bioscience, Inc.

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

An Octanoate breath test will be used to assess the presence of Hepatocellular Carcinoma in subjects with risk. The gold standard will be MRI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100039
        • 302 Military Hopsital
      • Beijing, China, 100700
        • General Hospital of Beijing Military Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Any patients with chronic liver disease at risk for HCC.
  2. Age ≥ 18 years.
  3. Patient has an MRI result (positive or negative for HCC) up to 3 months prior to recruitment or will be scheduled for an MRI during the trial period.
  4. Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.

Exclusion Criteria:

  1. Any patients with chronic liver disease at risk for HCC.
  2. Age ≥ 18 years.
  3. Patient has an MRI result (positive or negative for HCC) up to 3 months prior to recruitment or will be scheduled for an MRI during the trial period.
  4. Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.
  5. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
  6. Women who are pregnant or breast feeding.
  7. Patient taking drugs that can interfere with octanoate metabolism or can also cause NAFLD independent of the metabolic syndrome, including: corticosteroids, amiodarone, tetracycline, valproic acid, methotrexate, stavudine, zidovudine.
  8. Patient, based on the opinion of the investigator, should not be enrolled into this study.
  9. Patient unable or unwilling to sign informed consent.
  10. Patients that are participating in other clinical trials evaluating experimental treatments or procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCC positive
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.
Device: ¹³C-Octanoate Breath Test
Octanoate Breath Test to be performed on subjects with suspected HCC
Other Names:
  • Caprylate
  • Sodium caprylate
Experimental: HCC negative
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.
Device: ¹³C-Octanoate Breath Test
Octanoate Breath Test to be performed on subjects with suspected HCC
Other Names:
  • Caprylate
  • Sodium caprylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
13CO2/12CO2 ratio
Time Frame: 60 minutes
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meridian Bioscience, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

June 5, 2016

First Submitted That Met QC Criteria

June 5, 2016

First Posted (Estimate)

June 9, 2016

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC-MPBA-0514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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