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Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis

Primary Purpose

Hepatocellular Carcinoma (HCC)

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
¹³C-Octanoate Breath Test
Sponsored by
Meridian Bioscience, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma (HCC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 302 Military Hopsital
  • General Hospital of Beijing Military Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HCC positive

HCC negative

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

13CO2/12CO2 ratio

Secondary Outcome Measures

Full Information

First Posted
June 5, 2016
Last Updated
December 19, 2022
Sponsor
Meridian Bioscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02794805
Brief Title
Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meridian Bioscience, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
An Octanoate breath test will be used to assess the presence of Hepatocellular Carcinoma in subjects with risk. The gold standard will be MRI.
Detailed Description
Informed consent will be obtained from all patients prior to enrollment. The trial will be conducted in compliance with this protocol, with GCP standards, and the applicable regulatory requirements. 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. All patients will undergo AFP and US if they do not have results within the past three months. If the patient undergoes liver FNA, the biopsy results will be evaluated for the presence of HCC. For all patients, a case report form will be completed. 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. If relevant (woman of child bearing age), a pregnancy test will be performed to rule out pregnancy when performing the breath test. All MRI negative patients with low OBT results will undergo additional MRI within 6 to 12 months post OBT to rule out HCC occurrence. If available, all additional MRI/CT/US results will be recorded within the patient's CRF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma (HCC)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCC positive
Arm Type
Experimental
Arm Description
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.
Arm Title
HCC negative
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
¹³C-Octanoate Breath Test
Other Intervention Name(s)
Caprylate, Sodium caprylate
Intervention Description
Octanoate Breath Test to be performed on subjects with suspected HCC
Primary Outcome Measure Information:
Title
13CO2/12CO2 ratio
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patients with chronic liver disease at risk for HCC. Age ≥ 18 years. 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. Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI. Exclusion Criteria: Any patients with chronic liver disease at risk for HCC. Age ≥ 18 years. 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. Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs. Women who are pregnant or breast feeding. 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. Patient, based on the opinion of the investigator, should not be enrolled into this study. Patient unable or unwilling to sign informed consent. Patients that are participating in other clinical trials evaluating experimental treatments or procedures
Facility Information:
Facility Name
302 Military Hopsital
City
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
General Hospital of Beijing Military Region
City
Beijing
ZIP/Postal Code
100700
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis

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