Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06210178
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-12-21
Brief Title:
Non-Invasive Portal and Hepatic Vein Pressure Estimation
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Non-Invasive Portal and Hepatic Vein Pressure Estimation MRI-Guided Diagnostics for Chronic Liver Disease
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NONEEDLES
Brief Summary:
Background Portal hypertension PH is a spectrum of complications of end-stage liver disease ESLD and cirrhosis with severe manifestations including ascites and gastroesophageal varices It is therefore important that timely and easily diagnosing PH has relevant prognostic and therapeutic implications The current gold standard to evaluate PH is by hepatic vein catheterization using the transjugular approach and measuring the hepatic venous pressure gradients HVPG
Time-resolved three-dimensional three-directional velocity-encoded MRI also termed four-dimensional 4D flow MRI has been shown superior accuracy over conventional two-dimensional 2D phase-contrast MRI in particular for quantification of regurgitant volumes and severity of cardiac shunts Recently the investigators developed new imaging methods based on 4D flow MRI for visualization of the vasculature of the abdominal blood flow circulation including the portal vein Using the newly developed computation fluid dynamics CFD model the investigators could determine the absolute local blood pressure in the portal vein Preliminary data in healthy volunteers seem promising however data in patients with ESLD including the correlation with invasively measured HVPG are lacking
Objectives The primary objective is to develop and validate noninvasive CFD and 4D Flow MRI based HVPG calculation to estimate portal pressure in patients with end-stage liver disease ESLD
Methods In 50 adult patients with ESLD submitted for liver transplantation LT screening HVPG measurements using the transjugular approach according to the standard LT screening protocol will be extended by 4D flow MRI measurements
Anticipated results In patients with ESLD portal pressure can be measured by 4D flow MRI and will replace the invasive transjugular approach The measurements can be directly incorporated in the LT screening Moreover the possibility to easily measure portal pressure will be relevant for all patients with ESLD at risk for PH
Nature and extent of the burden and risks associated with participation benefit and group relatedness
Patients will undergo a single non-invasive MRI-examination of one hour long after a four hour period of fasting The risks associated with non-invasive MRI examinations is neglectable
Time-resolved three-dimensional three-directional velocity-encoded MRI also termed four-dimensional 4D flow MRI has been shown superior accuracy over conventional two-dimensional 2D phase-contrast MRI in particular for quantification of regurgitant volumes and severity of cardiac shunts Recently the investigators developed new imaging methods based on 4D flow MRI for visualization of the vasculature of the abdominal blood flow circulation including the portal vein Using the newly developed computation fluid dynamics CFD model the investigators could determine the absolute local blood pressure in the portal vein Preliminary data in healthy volunteers seem promising however data in patients with ESLD including the correlation with invasively measured HVPG are lacking
Objectives The primary objective is to develop and validate noninvasive CFD and 4D Flow MRI based HVPG calculation to estimate portal pressure in patients with end-stage liver disease ESLD
Methods In 50 adult patients with ESLD submitted for liver transplantation LT screening HVPG measurements using the transjugular approach according to the standard LT screening protocol will be extended by 4D flow MRI measurements
Anticipated results In patients with ESLD portal pressure can be measured by 4D flow MRI and will replace the invasive transjugular approach The measurements can be directly incorporated in the LT screening Moreover the possibility to easily measure portal pressure will be relevant for all patients with ESLD at risk for PH
Nature and extent of the burden and risks associated with participation benefit and group relatedness
Patients will undergo a single non-invasive MRI-examination of one hour long after a four hour period of fasting The risks associated with non-invasive MRI examinations is neglectable
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None