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

Primary Purpose

Chronic Liver Disease, Hepatocellular Carcinoma (HCC)

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

13C Sodium Octanoate

About this trial

This is an interventional diagnostic trial for Chronic Liver Disease focused on measuring HCC Hepatocellular carcinoma, OBT Octanoate Breath Test

Eligibility Criteria

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

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 any HCC treatment.

Exclusion Criteria:

Underwent any RFA or TACE or Oral HCC treatments.
Portal vein thrombosis.
Prior TIPS placement.
Severe congestive heart failure (LVEF on echocardiogram < 20%).
Severe pulmonary hypertension (By echocardiogram, PAS >45 mmHg).
Uncontrolled diabetes mellitus (HBA1C >9.5%).
Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication.
Previous surgical bypass surgery for morbid obesity (BMI >45).
Extensive small bowel resection.
Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
Women who are pregnant or breast feeding.
Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma.
Patient has taken 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 is unable or unwilling to sign informed consent.
Patients that are participating in other clinical trials evaluating experimental treatments or procedures

Sites / Locations

Toronto General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Octanaote Breath Test

Arm Description

A Octanoate breath test will be performed on this single arm population

Outcomes

Primary Outcome Measures

PDR Peak

PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.

Secondary Outcome Measures

Full Information

NCT ID

NCT01433016

First Posted

September 11, 2011

Last Updated

December 19, 2022

Sponsor

Meridian Bioscience, Inc.

Collaborators

Toronto General Hospital, Medical University of South Carolina, Northwestern University, Henry Ford Health System, Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT01433016

Brief Title

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

Acronym

OBT for HCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Terminated

Why Stopped

Due to budgetary issues, the company has decided to focus on other applications at this stage.

Study Start Date

November 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meridian Bioscience, Inc.

Collaborators

Toronto General Hospital, Medical University of South Carolina, Northwestern University, Henry Ford Health System, Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

The Octanoate Breath Test (OBT) developed by Exalenz is performed by the BreathID System consists of the BreathID device and a test kit containing a nasal cannula, a calibration gas container and a non-radioactive isotope ¹³C- Octanoate solution, and measures and computes the ratio between ¹³CO2 and 12CO2 in the patient's exhaled breath. This study's aim is to provide data on this novel system to dynamically and accurately assess liver function at the bed side. It is hoped that the system will provide prognostic information faster than is achieved at present with traditional methods. It is hypothesized that in the future the OBT may have an impact on decision making and clinical practice in this group of HCC patients, allowing a greater chance for proper management and hence survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Liver Disease, Hepatocellular Carcinoma (HCC)

Keywords

HCC Hepatocellular carcinoma, OBT Octanoate Breath Test

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Octanaote Breath Test

Arm Type

Experimental

Arm Description

A Octanoate breath test will be performed on this single arm population

Intervention Type

Drug

Intervention Name(s)

13C Sodium Octanoate

Intervention Description

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.

Primary Outcome Measure Information:

Title

PDR Peak

Description

PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.

Time Frame

At study day one after one hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 any HCC treatment. Exclusion Criteria: Underwent any RFA or TACE or Oral HCC treatments. Portal vein thrombosis. Prior TIPS placement. Severe congestive heart failure (LVEF on echocardiogram < 20%). Severe pulmonary hypertension (By echocardiogram, PAS >45 mmHg). Uncontrolled diabetes mellitus (HBA1C >9.5%). Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication. Previous surgical bypass surgery for morbid obesity (BMI >45). Extensive small bowel resection. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs. Women who are pregnant or breast feeding. Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma. Patient has taken 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 is unable or unwilling to sign informed consent. Patients that are participating in other clinical trials evaluating experimental treatments or procedures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Morris Sherman, MD

Organizational Affiliation

Toronto General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto General Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2N2

Country

Canada

12. IPD Sharing Statement

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

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