NCT04782531

Brief Summary

The analysis of portal vein blood flow is important when assessing the severity and progression of liver disease. It is important to understand normal liver regulation in order to appreciate the evaluation of the effect of treatment during the disease progression. The influence of respiration on hepatic hemodynamics is still poorly understood, although some studies have shown a significant impact. The purpose of this project is to quantify the blood flow variations in the portal vein at different positions during the respiratory cycle by using a fast MRI sequence and an Echo Planar (EPI) acquisition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2024

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

March 2, 2021

Last Update Submit

May 23, 2025

Conditions

Respiratory AmplitudePortal Blood FlowMRIEcho Planar Imaging

Keywords

Respiratory amplitudePortal Blood FlowMRIEcho Planar Imaging

Outcome Measures

Primary Outcomes (1)

  • flow rates variation between the fast sequence averaged values and the standard sequence

    flow rates variation between the fast sequence averaged values and the standard sequence during free breathing.

    30 minutes

Interventions

peripheral ECGOTHER

Subjects will be placed in supine position. The systematic use of a headset will reduce the noise inherent to the machine. A cardiac synchronization system using peripheral ECG allows the synchronization with the subject's heart rate.

Standard MRIOTHER

Standard MRI examination using a torso coil consists of morphological and phase-contrast flow sequences(standard and EPI acquisitions).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 ans
  • Healthy subject without history of hepatic disease

You may not qualify if:

  • history of hepatic pathology
  • pregnant woman
  • claustrophobia
  • major obesity
  • any contraindication to MRI exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 4, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2023

Study Completion

October 7, 2024

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)