FibroScan ® Study: Assessing Liver Fibrosis in Patients Using Methotrexate for Psoriasis
NCT03820934 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2020-07-23
Summary
The purpose of this study is to validate FibroScan and FibroSURE™ as equal or superior alternatives to liver biopsy for the monitoring and detection of methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
Fibroscan and Fibrosure
Patient's will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these tests. Fibroscan uses vibrations sent through the liver to measure its stiffness and the fibrosure uses laboratory and demographic parameters to create a score associated with a certain level of fibrosis. The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.
Sponsors & Collaborators
-
University Hospitals Cleveland Medical Center
lead OTHER
Principal Investigators
-
Neil Korman, MD · University Hospitals Cleveland Medical Center
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-10
- Primary Completion
- 2019-05-15
- Completion
- 2019-05-15
- FDA Device
- Yes
Countries
- United States
Study Locations
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