Status:
COMPLETED
Characterization and Technical Evaluation of cT1 for NASH (CATE-NASH)
Lead Sponsor:
Perspectum
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-75 years
Brief Summary
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 wil...
Detailed Description
This is a prospective, case-control, study designed to measure the mean difference in cT1 and PDFF in patients who have undergone liver biopsy and have confirmed NASH and fibrosis or 'cases' (N=40) an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 12 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04341246
Start Date
January 28 2021
End Date
June 12 2023
Last Update
January 3 2024
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114