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

September 11, 2011
April 8, 2014
November 2011
May 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01433016 on ClinicalTrials.gov Archive Site
Not Provided
Correlation of OBT to tumor size [ Time Frame: Within 3 months of breath test ] [ Designated as safety issue: No ]
To correlate the OBT measurements to the size of the tumors based on information derived from MRI.
Not Provided
Not Provided
 
Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Chronic Liver Disease
  • Hepatocellular Carcinoma (HCC)
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.
Experimental: Octanaote Breath Test
A Octanoate breath test will be performed on this single arm population
Intervention: Drug: 13C Sodium Octanoate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
May 2013
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01433016
HCC-BID-0411
No
Exalenz Bioscience LTD.
Exalenz Bioscience LTD.
  • Toronto General Hospital
  • Medical University of South Carolina
  • Northwestern University
  • Henry Ford Health System
  • Hadassah Medical Organization
Principal Investigator: Morris Sherman, MD Toronto General Hospital
Exalenz Bioscience LTD.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP