Usefulness of Controlled Attenuation Parameter (CAP) for the Assessment of Liver Steatosis
Overview
Tab Title Description
Study type
ObservationalDescribes 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
- Rochester, Minnesota: 17-005100
Sponsor Protocol Number: 17-005100
About this study
The primary aim of this study is to determine the accuracy of CAP from Fibroscan in the quantification of liver steatosis in donors using liver biopsies as the gold standard.
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:
Liver Recipient
- Men and women
- Age 18-years old to 80-years old inclusive
Liver Donor
- Valid TE with Fibroscan 530, defined as:
- At least 10 valid measurements
- IQR/Median stiffness value <30% (only in cases with >7.1 kPa)
Exclusion Criteria:
Liver Recipient
- Patient did not undergo liver transplantation
Liver Donor
- Donation after circulatory death (DCD)
- No liver biopsy obtained during organ procurement process
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Julie Heimbach, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available