Hepatocellular Carcinoma (HCC)Phase 2NCT02794805
Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis
A Phase 2 study testing ¹³C-Octanoate Breath Test in people with Hepatocellular Carcinoma (HCC), run by Meridian Bioscience, Inc. at 2 sites in China.
Trial summary
An Octanoate breath test will be used to assess the presence of Hepatocellular Carcinoma in subjects with risk. The gold standard will be MRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- ¹³C-Octanoate Breath Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2015to Apr 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.
Who cannot 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 HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.
- Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
- Women who are pregnant or breast feeding.
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- Patient taking 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 unable or unwilling to sign informed consent.
- Patients that are participating in other clinical trials evaluating experimental treatments or procedures
Trial locations and contacts
2 sites in 1 country.
China2 sites
302 Military Hopsital
Beijing, 100039
General Hospital of Beijing Military Region
Beijing, 100700
About this study
Official title: Evaluation of the Capability of the ¹³C-Octanoate Breath Test (OBT) Measurement to Differentiate Between Presence and Absence of HCC Determined by MRI in Patients With Chronic Liver Disease
An Octanoate breath test will be used to assess the presence of Hepatocellular Carcinoma in subjects with risk. The gold standard will be MRI.
Read the detailed description
- Informed consent will be obtained from all patients prior to enrollment.
- The trial will be conducted in compliance with this protocol, with GCP standards, and the applicable regulatory requirements.
- This study will be cross-sectional, where patients will be enrolled on a walk in basis. Once one arm is completed the other one will be enriched in order to obtain at least 50 positive and at least 50 negative HCC subjects as defined by MRI.
- All patients will undergo AFP and US if they do not have results within the past three months.
- If the patient undergoes liver FNA, the biopsy results will be evaluated for the presence of HCC.
- For all patients, a case report form will be completed.
- All patients will undergo a physical examination, and their medical history/concomitant medications, weight, height and age will be recorded. Furthermore, recent (past 3 months) blood test results, if available, may be recorded.
- If relevant (woman of child bearing age), a pregnancy test will be performed to rule out pregnancy when performing the breath test.
- All MRI negative patients with low OBT results will undergo additional MRI within 6 to 12 months post OBT to rule out HCC occurrence.
- If available, all additional MRI/CT/US results will be recorded within the patient's CRF.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- ¹³C-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-Octanoate Breath TestDevice
Also called Caprylate, Sodium caprylate
Octanoate Breath Test to be performed on subjects with suspected HCC
| Study group | Role | What they receive |
|---|---|---|
| HCC positive | Experimental | Breath testing utilizing 13C is a safe, non-invasive means for measuring a certain pathway's metabolic rate. 13C is a stable, non-radioactive isotope which can be incorporated into a specific location within a test substrate so it would be released when the compound is metabolized by the liver. Hepatic metabolism of the compound is assessed by measuring the ratio of 13CO2/12CO2 in exhaled breath. Receives: Device: ¹³C-Octanoate Breath Test |
| HCC negative | Experimental | Breath testing utilizing 13C is a safe, non-invasive means for measuring a certain pathway's metabolic rate. 13C is a stable, non-radioactive isotope which can be incorporated into a specific location within a test substrate so it would be released when the compound is metabolized by the liver. Hepatic metabolism of the compound is assessed by measuring the ratio of 13CO2/12CO2 in exhaled breath. Receives: Device: ¹³C-Octanoate Breath Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
13CO2/12CO2 ratio
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794805
- Sponsor's protocol ID
- HCC-MPBA-0514
- Status last verified
- Dec 2022
- First submitted
- 5 Jun 2016
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 to Differentiate Between Presence and Absence of HCC Determined by MRI in Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT02794805
- Acronym / sponsor ID
- HCC-MPBA-0514
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Octanoate breath test will be used to assess the presence of Hepatocellular Carcinoma in subjects with risk. The gold standard will be MRI.
Detailed description
- Informed consent will be obtained from all patients prior to enrollment.
- The trial will be conducted in compliance with this protocol, with GCP standards, and the applicable regulatory requirements.
- This study will be cross-sectional, where patients will be enrolled on a walk in basis. Once one arm is completed the other one will be enriched in order to obtain at least 50 positive and at least 50 negative HCC subjects as defined by MRI.
- All patients will undergo AFP and US if they do not have results within the past three months.
- If the patient undergoes liver FNA, the biopsy results will be evaluated for the presence of HCC.
- For all patients, a case report form will be completed.
- All patients will undergo a physical examination, and their medical history/concomitant medications, weight, height and age will be recorded. Furthermore, recent (past 3 months) blood test results, if available, may be recorded.
- If relevant (woman of child bearing age), a pregnancy test will be performed to rule out pregnancy when performing the breath test.
- All MRI negative patients with low OBT results will undergo additional MRI within 6 to 12 months post OBT to rule out HCC occurrence.
- If available, all additional MRI/CT/US results will be recorded within the patient's CRF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC positive | Experimental | Device: ¹³C-Octanoate Breath TestBreath testing utilizing 13C is a safe, non-invasive means for measuring a certain pathway's metabolic rate. 13C is a stable, non-radioactive isotope which can be incorporated into a specific location within a test substrate so it would be released when the compound is metabolized by the liver. Hepatic metabolism of the compound is assessed by measuring the ratio of 13CO2/12CO2 in exhaled breath. |
| HCC negative | Experimental | Device: ¹³C-Octanoate Breath TestBreath testing utilizing 13C is a safe, non-invasive means for measuring a certain pathway's metabolic rate. 13C is a stable, non-radioactive isotope which can be incorporated into a specific location within a test substrate so it would be released when the compound is metabolized by the liver. Hepatic metabolism of the compound is assessed by measuring the ratio of 13CO2/12CO2 in exhaled breath. |
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 HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.
Key exclusion criteria (10 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 HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.
- Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
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-Octanoate Breath TestAlso: Caprylate, Sodium caprylateOctanoate Breath Test to be performed on subjects with suspected HCC | Device | HCC negative, HCC positive |
Primary outcome
13CO2/12CO2 ratio
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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-Octanoate Breath Test in people with Hepatocellular Carcinoma (HCC), run by Meridian Bioscience, Inc. at 2 sites in China.
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 10 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: finished, 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 2 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
13CO2/12CO2 ratio (time frame: 60 minutes). 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.