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:
Exalenz Bioscience LTD.
Collaborators:
Toronto General Hospital
Medical University of South Carolina
Northwestern University,USA
Henry Ford Health System,USA
Hadassah Medical Center,Israel
Information provided by (Responsible Party):
Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier:
NCT01433016
First received: September 11, 2011
Last updated: May 21, 2012
Last verified: September 2011
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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:
MedlinePlus related topics:
Liver Diseases
Drug Information available for:
Sodium caprylate
U.S. FDA Resources
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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 110 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
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
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,USA
Henry Ford Health System,USA
Hadassah Medical Center,Israel
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 |
| Last Updated: | May 21, 2012 |
| 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 May 19, 2013