Quantitative Assessment of Skin and Liver of Patients with Diffuse Systemic Sclerosis Using Shear-Wave Ultrasound Elastography
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 21-002439
About this study
This study aims to evaluate if the skin thickness (the measurement of the dermis) or stiffness as part of the US-SWE exam as we can see it on grayscale US differs between SSc patients and controls and to evaluate if there is associated liver stiffness by US-SWE in patients with SSc as compared to controls.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years.
- 2013 ACR/EULAR classification criteria for SSc fulfilled and all patients with dSSc.
- We will allow enrolled patients to be on any kind of immunosuppressant medications, including but not limited to steroids, methotrexate, azathioprine, mycophenolate, rituximab, cyclophosphamide, or on the newly approved antifibrotic medication nintedanib.
Exclusion Criteria:
- Previous or planned hematopoietic stem cell transplantation.
- Active neoplasm of any kind.
- Previously known liver disease, including, but not limited to alcohol-induced liver cirrhosis.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Nirvikar Dahiya, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available