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NCT02821078 Clinical Trial

Evaluation of 4D Magnetic Resonance Flow Sequence at Hepatic Level

Magnetic Resonance Imaging Clinical Trial

— HEPAFLUX  

Official title:
Evaluation of 4D Magnetic Resonance Flow Sequence at Hepatic Level

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02821078
Other study ID # PI2016_843_0010
Secondary ID 2016-A00641-50
Status Completed
Phase N/A
First received
Last updated
Start date March 16, 2017
Est. completion date January 24, 2019

Study information
Verified date December 2020
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date January 24, 2019
Est. primary completion date January 24, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• 4D flow imaging sequence
4D flow imaging sequence

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Hepatic blood flow difference difference between (hepatic artery + portal vein flows) and inferior vena cava differential flow (infra and supra hepatic) Day 0
Secondary Comparison between 4D and 2D flow Comparison between 4D and 2D flow values measured at the portal trunk level Day 0
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