Ignite Creation Date:
2024-05-06 @ 12:14 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03704792
Status:
COMPLETED
Last Update Posted:
2022-08-08
First Post:
2018-10-10
Brief Title:
Validation of the Second Generation of the Controlled Attenuation Parameter CAP Using the MRI-PDFF as Reference
Sponsor:
Echosens
Organization:
Echosens
Study Overview
Official Title:
Validation of the Second Generation of the Controlled Attenuation Parameter CAP Using the MRI-PDFF as Reference
Status:
COMPLETED
Status Verified Date:
2022-08
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:
None
Brief Summary:
Chronic liver diseases CLDs represent a major worldwide public health burden Worldwide estimations show that 844 million people have CLDs a lot more than other chronic diseases such as diabetes or cardiovascular diseases CLD is most of the time an asymptomatic progressive and potentially fatal disease With its complications it becomes one of the major causes of mortality worldwide Globally hepatitis B virus and hepatitis C virus alcoholic liver disease and non-alcoholic steatohepatitis are the most important causes of liver disease
The diagnosis of liver lesions remains an important issue for these patients The prognosis and management of liver disease greatly depends on the amount of liver fibrosis In early stages it is the main factor predicting long-term outcome of these patients The liver biopsy still represents the gold standard diagnostic tool for liver fibrosis assessment although a wide spectrum of noninvasive tools are now commonly used as a surrogate to the liver biopsy It includes direct and indirect serum markers of liver fibrosis but also several imaging-based methods including transient elastography FibroScan Echosens Paris France
Even if the liver fibrosis is the key pathological feature of progressive liver disease the accumulation of excessive hepatic triglyceride hepatic steatosis is today recognized as an important factor in the pathogenesis of a number of CLD The magnetic resonance imaging MRI techniques are sensitive to steatosis and show interesting diagnostic performances especially the MRI using the proton density fat fraction MRI-PDFF which has shown at least equivalence in accuracy for quantifying hepatic steatosis with both 1H Magnetic Resonance Spectroscopy and with histological grade across several studies Therefore this technique is now part of the gold standard diagnostic tool to establish the grade of hepatic steatosis Echosens has developed an ultrasonic controlled attenuation parameter CAP designed to quantify hepatic steatosis using a process based on vibration controlled transient elastography VCTE
Echosens is working on improving the diagnostic accuracy of the CAP measurement performed with the FibroScan This protocol is set-up to compare the diagnostic performances of the first generation of the CAP and the second generation of the CAP to the reference the MRI-PDFF in patients with CLD all etiologies combined
The diagnosis of liver lesions remains an important issue for these patients The prognosis and management of liver disease greatly depends on the amount of liver fibrosis In early stages it is the main factor predicting long-term outcome of these patients The liver biopsy still represents the gold standard diagnostic tool for liver fibrosis assessment although a wide spectrum of noninvasive tools are now commonly used as a surrogate to the liver biopsy It includes direct and indirect serum markers of liver fibrosis but also several imaging-based methods including transient elastography FibroScan Echosens Paris France
Even if the liver fibrosis is the key pathological feature of progressive liver disease the accumulation of excessive hepatic triglyceride hepatic steatosis is today recognized as an important factor in the pathogenesis of a number of CLD The magnetic resonance imaging MRI techniques are sensitive to steatosis and show interesting diagnostic performances especially the MRI using the proton density fat fraction MRI-PDFF which has shown at least equivalence in accuracy for quantifying hepatic steatosis with both 1H Magnetic Resonance Spectroscopy and with histological grade across several studies Therefore this technique is now part of the gold standard diagnostic tool to establish the grade of hepatic steatosis Echosens has developed an ultrasonic controlled attenuation parameter CAP designed to quantify hepatic steatosis using a process based on vibration controlled transient elastography VCTE
Echosens is working on improving the diagnostic accuracy of the CAP measurement performed with the FibroScan This protocol is set-up to compare the diagnostic performances of the first generation of the CAP and the second generation of the CAP to the reference the MRI-PDFF in patients with CLD all etiologies combined
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