Evaluating the Required Controlled Attenuation Parameter (CAP) Value for a Magnetic Resonance Imaging Derived Proton Density Fat Fraction (MRI-PDFF) of Above 8%

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Mentor Information

Guy Neff (Department of Hepatology)

Description

In a clinic where the patients are expected to meet certain numbers to be included in a trial, it can become difficult to find a clear value range to know if a patient will qualify in a trial or not. Two important values that are often looked at are the magnetic resonance imagining derived proton density fat fraction (MRI-PDFF) and the controlled attenuation parameter (CAP). For PDFF values, Covenant currently looks for a value of above 8%. This project will dive into finding what CAP value can we find to know the PDFF value will be above 8%. Data was collected from 105 patients that have been randomized within two NAFLD trails, Madrigal 14 (MGL 14) and Madrigal 11 (MGL 11), at a large clinical research center. The data consists of CAP values, MRI-PDFF values, obesity, and hypertension. It was broken into three groups (CAP 248 – 280, 281 – 300, and 300 and above) and evaluated. The above results suggest that patient with CAP score greater than 280 will have a PDFF value of >8% consistently elevated suggesting of NASH.

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Evaluating the Required Controlled Attenuation Parameter (CAP) Value for a Magnetic Resonance Imaging Derived Proton Density Fat Fraction (MRI-PDFF) of Above 8%

In a clinic where the patients are expected to meet certain numbers to be included in a trial, it can become difficult to find a clear value range to know if a patient will qualify in a trial or not. Two important values that are often looked at are the magnetic resonance imagining derived proton density fat fraction (MRI-PDFF) and the controlled attenuation parameter (CAP). For PDFF values, Covenant currently looks for a value of above 8%. This project will dive into finding what CAP value can we find to know the PDFF value will be above 8%. Data was collected from 105 patients that have been randomized within two NAFLD trails, Madrigal 14 (MGL 14) and Madrigal 11 (MGL 11), at a large clinical research center. The data consists of CAP values, MRI-PDFF values, obesity, and hypertension. It was broken into three groups (CAP 248 – 280, 281 – 300, and 300 and above) and evaluated. The above results suggest that patient with CAP score greater than 280 will have a PDFF value of >8% consistently elevated suggesting of NASH.