Status:
TERMINATED
Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI
Lead Sponsor:
Meridian Bioscience, Inc.
Collaborating Sponsors:
Toronto General Hospital
Medical University of South Carolina
Conditions:
Chronic Liver Disease
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 th...
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 no...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01433016
Start Date
November 1 2011
End Date
May 1 2013
Last Update
December 20 2022
Active Locations (1)
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1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2