HCCNCT02415283
OBT Measurement to Differentiate Between Presence and Absence of HCC Determined by MRI
An observational study of HCC, run by Beijing 302 Hospital.
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 to differentiate between presence and absence of HCC determined by Magnetic Resonance Imaging (MRI) in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC
- What is being tested?
- ¹³C-Octanoate Breath Test
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2016
- Phase
- Observational
- 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
Study population: The proposed study will include subjects with chronic liver disease of any cause at risk for HCC with MRI results within 3 months prior to OBT or scheduled for MRI within the time frame of the study, and who meet the inclusion criteria and none of the exclusion criteria.
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
No sites are listed yet.
Dan R Peres, MD contact
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
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 to differentiate between presence and absence of HCC determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.
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
- HCC
- Being tested
- ¹³C-Octanoate Breath Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
¹³C-Octanoate Breath TestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HCC positive | ¹³C-Octanoate Breath Test in 50 MRI proven HCC positive patients Receives: Device: ¹³C-Octanoate Breath Test | |
| HCC negative | ¹³C-Octanoate Breath Test in 50 MRI proven HCC negative patients 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: 60min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongping Yang, Beijing 302 Hospital
- Investigators
- yongping yang, Prof, Principal investigator, Cooperation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415283
- Sponsor's protocol ID
- HCC-MPBA-0514
- Status last verified
- Apr 2015
- First submitted
- 9 Apr 2015
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. 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
- NCT02415283
- Acronym / sponsor ID
- HCC-MPBA-0514
- Conditions
- HCC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 Apr 2015 (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.
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 to differentiate between presence and absence of HCC determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC positive | – | Device: ¹³C-Octanoate Breath Test¹³C-Octanoate Breath Test in 50 MRI proven HCC positive patients |
| HCC negative | – | Device: ¹³C-Octanoate Breath Test¹³C-Octanoate Breath Test in 50 MRI proven HCC negative patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The proposed study will include subjects with chronic liver disease of any cause at risk for HCC with MRI results within 3 months prior to OBT or scheduled for MRI within the time frame of the study, and who meet the inclusion criteria and none of the exclusion criteria.
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 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. | Device | HCC negative, HCC positive |
Primary outcome
13CO2/12CO2 ratio
Time frame: 60min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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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.
Dan R Peres, MD contact
yongping yang, Prof principal investigator
Cooperation
Questions about this trial
What is this clinical trial studying?
An observational study of HCC, run by Beijing 302 Hospital.
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: status not confirmed, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan R Peres, MD (danp@exalenz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
13CO2/12CO2 ratio (time frame: 60min). 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 14 Apr 2015.