Characterization and Technical Evaluation of cT1 for NASH (CATE-NASH)

NCT04341246 | Completed FDA Device

• 1 other identifier: IIP-174
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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 will be divided into 2 sub groups comprising of cases and controls.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

NASH; Livermultiscan; fatty liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  1 day

• 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

  2-4 weeks

Study Arms (2)

Cases

Cases are defined as those patients who have undergone liver biopsy and have confirmed NASH and fibrosis

Device: LiverMultiscan

Controls

Controls are patients have undergone a liver biopsy with neither significant NASH nor significant fibrosis

Device: LiverMultiscan

Interventions

LiverMultiscan DEVICE

The Livermultiscan is a quick, 15 minute contrast free MRI scan that provided metrics to quantify liver health namely fat, iron and fibro-inflammation

Also known as: LMS

Cases; Controls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients, deemed to be suitable for inclusion into a NASH clinical trial based on their clinical risk factors, and who have been referred for a standard of care diagnostic liver biopsy on suspicion of NASH

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Perspectum: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Kathleen, Corey,, MD, MPH, MMSc

  MGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: January 28, 2021
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

US (1)