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

NCT04341246 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2024-01-03

No results posted yet for this study

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

Interventions

DEVICE

LiverMultiscan

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

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Perspectum

    lead INDUSTRY

Principal Investigators

  • Kathleen, Corey,, MD, MPH, MMSc · MGH

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-28
Primary Completion
2023-06-12
Completion
2023-06-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04341246 on ClinicalTrials.gov