- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01433016
Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI (OBT for HCC)
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 Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2N2
- Toronto General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Octanaote Breath Test
A Octanoate breath test will be performed on this single arm population
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PDR Peak
Time Frame: At study day one after one hour
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PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.
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At study day one after one hour
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Morris Sherman, MD, Toronto General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCC-BID-0411
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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