Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
Characterization and Technical Evaluation of cT1 for NASH (CATE-NASH): A Case-control Study
NCT number | NCT04341246 |
Other study ID # | IIP-174 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 28, 2021 |
Est. completion date | June 12, 2023 |
Verified date | January 2024 |
Source | Perspectum |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary objective of this study is to evaluate to provide evidence to establish tightly defined cut-offs to identify patients for NASH clinical trial inclusion using cT1 and/or PDFF. The study will be divided into 2 sub groups comprising of cases and controls.
Status | Completed |
Enrollment | 28 |
Est. completion date | June 12, 2023 |
Est. primary completion date | June 12, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Male and female subjects aged between 18-75 years - Ability to understand and sign a written informed consent form (ICF) - Patients who have undergone a liver biopsy within the last 6 weeks because of clinical suspicion on NAFL-D Exclusion Criteria: - Prior or planned liver transplantation - Patients who have undergone a laparoscopic or wedge liver biopsy, or biopsy taken from the left lobe - Participation in an investigational new drug (IND) trial in the 30 days before enrolment (except those patients who were not administered the IND) - Other known causes of chronic liver disease based on clinical criteria at the study site, such as the following: - Alcoholic liver disease - Primary biliary cirrhosis - Primary sclerosing cholangitis - Autoimmune hepatitis - Wilson's disease, hemochromatosis, iron overload - Alpha-1-antitrypsin (A1AT) deficiency - Hepatitis C Virus, Hepatitis B Virus - History or diagnosis of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding - Clinically relevant (more than 3 drinks per day on average for men and 2 for women) alcohol abuse within 12 months of liver biopsy and/or any recreational drugs - Any contradiction or significant limitation to Magnetic Resonance imaging (MRI) scanning including but not limited to the following: - Claustrophobia preventing Magnetic Resonance imaging (requires 15-30 minutes in scanner) - Pacemaker or another implanted electronic device - Metal in body (such as aneurysm clip) that might produce artefact on abdominal MRI or might be adversely impacted by a high magnetic field - Inability to lie flat, remain till, or briefly hold breath as necessary during MR imaging - Medical condition likely to produce significant hypervolemia like congestive heart failure - Severe obesity complicating positioning within MR scanner - Concomitant medical illnesses per investigators discretion that would hamper patient's completion of the study or otherwise affect the collected data (such as HIV infection, recent major surgery, uncontrolled heart disease, concurrent infection or fever of unknown origin, illicit drug use, cancer) - Clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study - Failure to give informed consent |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Perspectum | Food and Drug Administration (FDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To demonstrate that a binary decision algorithm applied to cT1 can significantly identify patients whose liver biopsy results would qualify them for randomization in a clinical trial testing an investigational treatment for NASH | Mean cT1 (and PDFF) values for those with NAS=4&F2-3 (cases) and those with NAS<4 or F<2 (controls) | 6 weeks | |
Secondary | To determine the measurement test-retest repeatability of cT1 and PDFF in the target patient population by examining the test-retest variability within a single scanning session | Difference between two replicates (Scan A and Scan B in same session) under the same measurement conditions expressed as the repeatability coefficient | 1 day | |
Secondary | To determine the biological repeatability of cT1 and PDFF in the target patient population by examining the test-retest variability between scans acquired under the same conditions but 2-4 weeks apart | Difference between two scans (Scan 1 and Scan 2) under the same measurement conditions expressed as the repeatability coefficient | 2-4 weeks |
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