Evaluation of 4D Magnetic Resonance Flow Sequence at Hepatic Level (HEPAFLUX)

December 3, 2020 updated by: Centre Hospitalier Universitaire, Amiens
The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants have fasted for 6 hours before examination
  • Adult participants

Exclusion Criteria:

  • Anyone with a classic contraindication to MRI
  • Recanalized umbilical vein
  • Severe obesity
  • Gadolinium chelate allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants

In addition to the standard clinical MR protocol, 2 added sequences:

  • 4D flow imaging sequence
  • standard 2D-PhaseContrast at portal trunk level as reference
Other: 4D flow imaging sequence
4D flow imaging sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between 4D and 2D flow
Time Frame: Day 0
Comparison between 4D and 2D flow values measured at the portal trunk level
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Thierry Yzet, MD, PhD, CHU Amiens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2017

Primary Completion (Actual)

January 24, 2019

Study Completion (Actual)

January 24, 2019

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2016_843_0010
  • 2016-A00641-50 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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