- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04782531
Variations of Portal Flow During the Respiratory Cycle in Healthy Volunteers (RESPIFLUX)
May 23, 2025 updated by: Centre Hospitalier Universitaire, Amiens
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
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
-
-
-
Amiens, France, 80480
- 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
Yes
Description
Inclusion Criteria:
- Age ≥ 18 ans
- Healthy subject without history of hepatic disease
Exclusion Criteria:
- history of hepatic pathology
- pregnant woman
- claustrophobia
- major obesity
- any contraindication to MRI exam
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
flow rates variation between the fast sequence averaged values and the standard sequence
Time Frame: 30 minutes
|
flow rates variation between the fast sequence averaged values and the standard sequence during free breathing.
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 1, 2021
Primary Completion (Actual)
March 1, 2023
Study Completion (Actual)
October 7, 2024
Study Registration Dates
First Submitted
March 2, 2021
First Submitted That Met QC Criteria
March 2, 2021
First Posted (Actual)
March 4, 2021
Study Record Updates
Last Update Posted (Actual)
May 29, 2025
Last Update Submitted That Met QC Criteria
May 23, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- PI2020_843_0150
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.