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

This study has been terminated.
(Due to budgetary issues, the company has decided to focus on other applications at this stage.)
Sponsor:
Collaborators:
Toronto General Hospital
Medical University of South Carolina
Northwestern University
Henry Ford Health System
Hadassah Medical Organization
Information provided by (Responsible Party):
Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier:
NCT01433016
First received: September 11, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Chronic Liver Disease
Hepatocellular Carcinoma (HCC)
Drug: 13C Sodium Octanoate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Exalenz Bioscience LTD.:

Primary Outcome Measures:
  • PDR Peak [ Time Frame: At study day one after one hour ] [ Designated as safety issue: No ]
    PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.


Enrollment: 20
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Octanaote Breath Test
A Octanoate breath test will be performed on this single arm population
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433016

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
Exalenz Bioscience LTD.
Toronto General Hospital
Medical University of South Carolina
Northwestern University
Henry Ford Health System
Hadassah Medical Organization
Investigators
Principal Investigator: Morris Sherman, MD Toronto General Hospital
  More Information

No publications provided

Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT01433016     History of Changes
Other Study ID Numbers: HCC-BID-0411
Study First Received: September 11, 2011
Results First Received: February 11, 2014
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Exalenz Bioscience LTD.:
HCC Hepatocellular carcinoma
OBT Octanoate Breath Test

Additional relevant MeSH terms:
Carcinoma
Liver Diseases
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on August 25, 2014