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

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ClinicalTrials.gov Identifier: NCT01433016
Recruitment Status : Terminated (Due to budgetary issues, the company has decided to focus on other applications at this stage.)
First Posted : September 13, 2011
Results First Posted : April 7, 2014
Last Update Posted : April 25, 2014
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.

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. PDR Peak [ Time Frame: At study day one after one hour ]
    PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT01433016     History of Changes
Other Study ID Numbers: HCC-BID-0411
First Posted: September 13, 2011    Key Record Dates
Results First Posted: April 7, 2014
Last Update Posted: April 25, 2014
Last Verified: April 2014

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

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