Magnetic Resonance ImagingHEPAFLUXNCT02821078
Evaluation of 4D Magnetic Resonance Flow Sequence at Hepatic Level
A study testing 4D flow imaging sequence in people with Magnetic Resonance Imaging, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- 4D flow imaging sequence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2017to 24 Jan 2019
- Phase
- Interventional
- 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
- Participants have fasted for 6 hours before examination
- Adult participants
Who cannot join
- Anyone with a classic contraindication to MRI
- Recanalized umbilical vein
- Severe obesity
- Gadolinium chelate allergy
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency
Read the detailed description
The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency. Specifically, the investigators will assess the consistency of the quantitative data by measuring hepatic blood Inflow (hepatic artery + portal vein) and outflow (inferior vena cava differential flow). According to the mass conservation physical property, blood inflow must equals blood outflow. The relative gap between the measured values will characterize the consistency of the acquisition.
- Conditions
- Magnetic Resonance Imaging
- Being tested
- 4D flow imaging sequence
- Keywords
- phase-contrast MRI, blood flow, velocity mapping, abdominal imaging, Quantitative MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D flow imaging sequenceOther
4D flow imaging sequence
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | In addition to the standard clinical MR protocol, 2 added sequences:
* 4D flow imaging sequence
* standard 2D-PhaseContrast at portal trunk level as reference Receives: Other: 4D flow imaging sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic blood flow difference
difference between (hepatic artery + portal vein flows) and inferior vena cava differential flow (infra and supra hepatic)
Measured: Day 0
Secondary outcomes (1)
Comparison between 4D and 2D flow
Comparison between 4D and 2D flow values measured at the portal trunk level
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start16 Mar 2017
- Primary completion24 Jan 2019
- Study completion24 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Yzet, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821078
- Sponsor's protocol ID
- PI2016_843_0010
- Other IDs
- 2016-A00641-50
- Acronym
- HEPAFLUX
- Status last verified
- Nov 2025
- First submitted
- 29 Jun 2016
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yzet T, Bouzerar R, Baledent O, Renard C, Lumbala DM, Nguyen-Khac E, Regimbeau JM, Deramond H, Meyer ME. Dynamic measurements of total hepatic blood flow with Phase Contrast MRI. Eur J Radiol. 2010 Jan;73(1):119-24. doi: 10.1016/j.ejrad.2008.09.032. Epub 2008 Nov 12.
PubMed 19008062
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 4D Magnetic Resonance Flow Sequence at Hepatic Level
- ClinicalTrials.gov ID
- NCT02821078
- Acronym / sponsor ID
- HEPAFLUX / PI2016_843_0010
- Conditions
- Magnetic Resonance Imaging
- Keywords
- phase-contrast MRI, blood flow, velocity mapping, abdominal imaging, Quantitative MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 1 Jul 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.
The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency
Detailed description
The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency. Specifically, the investigators will assess the consistency of the quantitative data by measuring hepatic blood Inflow (hepatic artery + portal vein) and outflow (inferior vena cava differential flow). According to the mass conservation physical property, blood inflow must equals blood outflow. The relative gap between the measured values will characterize the consistency of the acquisition.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Other: 4D flow imaging sequenceIn addition to the standard clinical MR protocol, 2 added sequences: * 4D flow imaging sequence * standard 2D-PhaseContrast at portal trunk level as reference |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants have fasted for 6 hours before examination
- Adult participants
Key exclusion criteria (4 listed)
- Anyone with a classic contraindication to MRI
- Recanalized umbilical vein
- Severe obesity
- Gadolinium chelate allergy
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 |
|---|---|---|
| 4D flow imaging sequence4D flow imaging sequence | Other | Participants |
Primary outcome
Hepatic blood flow difference
Time frame: Day 0
difference between (hepatic artery + portal vein flows) and inferior vena cava differential flow (infra and supra hepatic)
1 secondary outcome
Comparison between 4D and 2D flow
Time frame: Day 0
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 19 Nov 2025.
- Results publication: PubMed 19008062Yzet T, Bouzerar R, Baledent O, Renard C, Lumbala DM, Nguyen-Khac E, Regimbeau JM, Deramond H, Meyer ME. Dynamic measurements of total hepatic blood flow with Phase Contrast MRI. Eur J Radiol. 2010 Jan;73(1):119-24. doi: 10.1016/j.ejrad.2008.09.032. Epub 2008 Nov 12.
- 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.
Thierry Yzet, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4D flow imaging sequence in people with Magnetic Resonance Imaging, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 2 inclusion and 4 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 19 Nov 2025. 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 France. 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.
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?
Hepatic blood flow difference (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02821078, which also lists 1 linked publication.
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 19 Nov 2025.