Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
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|ClinicalTrials.gov Identifier: NCT04054310|
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|NASH - Nonalcoholic Steatohepatitis||Diagnostic Test: Liver Multi Scan||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-Invasive Quantification of Liver Health in NASH (N-QUAN): A Prospective Diagnostic Accuracy Study|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
Experimental: Study arm
Only one arm, so not necessary.
Diagnostic Test: Liver Multi Scan
MRI to create cT1, T2* and PDFF images of patients liver.
Other Name: Biopsy
- Diagnostic performance of cT1 [ Time Frame: 12 months ]To evaluate, in patients with suspected Nash referred for Liver biopsy, the diagnostic performance of cT1 at discriminating those patients with NAS≥4 & F≥2 from those patients without. In order to evaluate the diagnostic performance area under the receiver operative curve (AUROC) will be analysised.
- Diagnostics performance of PDFF [ Time Frame: 12 months ]To evaluate, inpatients with suspected NASH referred for liver biopsy, the diagnostic performance of PDFF at discriminating those with NAS≥4 from those without, and those with Brunt Steatosis≥2 from those without. The diagnostic performance will be determined using area under the receiver operative curve (AUROC) analysis.
- Correlation between cT1 and hisopathological features [ Time Frame: 12 months ]To assess the correlation between cT1 and histopathological features of NASH and PDFF and histopathological features of NASH. The correlations will be explored using Spearman's Rho
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054310
|Contact: Arun Sanyalemail@example.com|
|Contact: Andrea Dennisfirstname.lastname@example.org|
|United States, Virginia|
|Virginia Common wealth University||Not yet recruiting|
|Richmond, Virginia, United States, 23284|
|Contact: Arun Sanyal, MD 804-828-4060 email@example.com|
|Contact: Rebecca Collen, BSC 8048280100 firstname.lastname@example.org|