search
Back to results

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
Sponsored by
Meridian Bioscience, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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
search

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
No

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
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 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

Learn more about this trial

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

We'll reach out to this number within 24 hrs