Chronic Liver DiseasePhase 2OBT for HCCNCT01433016
Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI
A Phase 2 study testing 13C Sodium Octanoate in people with Chronic Liver Disease and Hepatocellular Carcinoma (HCC), run by Meridian Bioscience, Inc. at 1 site in Canada.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease, Hepatocellular Carcinoma (HCC)
- What is being tested?
- 13C Sodium Octanoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- 13C Sodium Octanoate
- Keywords
- HCC Hepatocellular carcinoma, OBT Octanoate Breath Test
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C Sodium OctanoateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Octanaote Breath Test | Experimental | A Octanoate breath test will be performed on this single arm population Receives: Drug: 13C Sodium Octanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PDR Peak
PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.
Measured: At study day one after one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionMay 2013
Why it stopped: Due to budgetary issues, the company has decided to focus on other applications at this stage.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Toronto General Hospital, Medical University of South Carolina, Northwestern University, Henry Ford Health System, Hadassah Medical Organization
- Responsible party
- Sponsor
- Investigators
- Morris Sherman, MD, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433016
- Sponsor's protocol ID
- HCC-BID-0411
- Acronym
- OBT for HCC
- Status last verified
- Dec 2022
- First submitted
- 11 Sep 2011
- Last updated
- 20 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01433016
- Acronym / sponsor ID
- OBT for HCC / HCC-BID-0411
- Keywords
- HCC Hepatocellular carcinoma, OBT Octanoate Breath Test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to budgetary issues, the company has decided to focus on other applications at this stage.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Toronto General Hospital, Medical University of South Carolina, Northwestern University, Henry Ford Health System, Hadassah Medical Organization
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Sep 2011 (estimated)
- Results
- Posted 7 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Octanaote Breath Test | Experimental | Drug: 13C Sodium OctanoateA Octanoate breath test will be performed on this single arm population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13C Sodium Octanoate13C 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. | Drug | Octanaote Breath Test |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morris Sherman, MD principal investigator
Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 13C Sodium Octanoate in people with Chronic Liver Disease and Hepatocellular Carcinoma (HCC), run by Meridian Bioscience, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PDR Peak (time frame: At study day one after one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.