Hepatocellular CarcinomaCHIC MultiANCT04687280
Comparison of Multiphase and Monophasic Arterial Hepatic MRI in the Detection of Arterial Enhancement of CHC Nodules
An observational study of Hepatocellular Carcinoma, run by University Hospital, Angers.
Trial summary
The detection and diagnosis of hepatocellular carcinoma is a public health issue. MRI is the most sensitive examination for diagnosis and especially hypervascularization in the arterial phase. Several studies have shown that MRI multiphase arterial sequences are superior to single phase to capture the arterial phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- non interventional
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2009to Dec 2018
- 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: patient followed up for cirrhosis with discovery of a suspicious CHC nodule during imaging monitoring
Who may be able to join
- patient included in CHIC study with histology of hepatocellular carcinoma
Who cannot join
- nodules already treated by chimioembolization
About this study
Official title: Comparison of Multiphase and Monophasic Arterial Hepatic MRI in the Detection of Arterial Enhancement of CHC Nodules in Cirrhotic Patients
The detection and diagnosis of hepatocellular carcinoma is a public health issue. MRI is the most sensitive examination for diagnosis and especially hypervascularization in the arterial phase.
Several studies have shown that MRI multiphase arterial sequences are superior to single phase to capture the arterial phase. The purpose of this study is to compare arterial enhancement sensibilities between multi and single phase sequences.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- non interventional
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non interventionalOther
non interventional, study on data
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial enhancement
significant arterial enhancement present in one of the three phases of multiphasic arterial time compared to all other arterial phases or single phase
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start22 Apr 2009
- Primary completion27 Oct 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687280
- Sponsor's protocol ID
- 2019-24b
- Acronym
- CHIC MultiA
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Multiphase and Monophasic Arterial Hepatic MRI in the Detection of Arterial Enhancement of CHC Nodules in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT04687280
- Acronym / sponsor ID
- CHIC MultiA / 2019-24b
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 22 Apr 2009 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 29 Dec 2020 (actual)
- 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 detection and diagnosis of hepatocellular carcinoma is a public health issue. MRI is the most sensitive examination for diagnosis and especially hypervascularization in the arterial phase.
Several studies have shown that MRI multiphase arterial sequences are superior to single phase to capture the arterial phase. The purpose of this study is to compare arterial enhancement sensibilities between multi and single phase sequences.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient followed up for cirrhosis with discovery of a suspicious CHC nodule during imaging monitoring
Key inclusion criteria (1 listed)
- patient included in CHIC study with histology of hepatocellular carcinoma
Key exclusion criteria (1 listed)
- nodules already treated by chimioembolization
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 |
|---|---|---|
| non interventionalnon interventional, study on data | Other | – |
Primary outcome
arterial enhancement
Time frame: 1 year
significant arterial enhancement present in one of the three phases of multiphasic arterial time compared to all other arterial phases or single phase
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 29 Dec 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by University Hospital, Angers.
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 1 inclusion and 1 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 29 Dec 2020. 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?
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?
arterial enhancement (time frame: 1 year). 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 29 Dec 2020.