Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03743272 |
| Other study ID # |
LMSRR |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 3, 2017 |
| Est. completion date |
November 1, 2022 |
Study information
| Verified date |
May 2021 |
| Source |
Perspectum |
| Contact |
Soubera Rymell, BSc |
| Phone |
+441865655343 |
| Email |
soubera.rymell[@]perspectum.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study aims to prospectively assess the repeatability and reproducibility of
iron-corrected T1 (cT1), T2*, and hepatic proton density fat fraction (PDFF) quantification
with multiparametric MRI using the LiverMultiScan™ (LMS, Perspectum Diagnostics, Oxford, UK)
protocol across different field strengths, scanner manufacturers and models.
Description:
As the burden of liver disease reaches epidemic levels, there is a high unmet medical need to
develop robust, accurate and reproducible non-invasive methods to quantify liver tissue
characteristics for use in clinical development and ultimately in clinical practice.
Repeatability and reproducibility validation studies are important in evaluating metrics,
such that any changes can be confidently attributed to disease progression or regression,
rather than inter-examination variability in the instrument.
Magnetic resonance (MR) techniques offer an attractive non-invasive option for liver
assessment. Multiparametric MRI is a safe and non-invasive method for quantification of liver
tissue characteristics. Images for quantification of hepatic fat from proton density fat
fraction (PDFF) maps, T2*, and iron-corrected T1 (cT1) can be rapidly obtained during
abdominal breath-hold acquisitions without the need for contrast agents or additional
external hardware. Iron correction of T1 is necessary to address the confounding effects of
excess iron, which is common in chronic liver disease. LiverMultiScan™ (LMS, Perspectum
Diagnostics, Oxford, UK) is a software application that can be used with supported MR-systems
to correct T1 for the effects of excess iron, and thus, to calculate cT1 from T1 and T2*
maps, and standardise to a 3T field strength.
This method has been shown to have high diagnostic accuracy for the assessment of liver
fibrosis compared to histology, predict clinical outcomes in patients with mixed liver
disease aetiology, stratify patients with non-alcoholic steatohepatitis (NASH) and cirrhosis,
reliably exclude clinically significant liver disease and is cost-effective in diagnosing
NAFLD.
In addition to demonstrating accuracy, imaging biomarker validation requires precision and
repeatability (US Department of Health and Human Services, 2015). From a clinical
perspective, it is essential to ensure that there is good inter-examination repeatability, so
that any changes seen can be correctly attributed to disease progression or regression,
rather than inter-examination variability. This is tested by examining the closeness of
repeated measurements made in different MR examinations (with both subject and coil
repositioning) over a time frame in which physiologic conditions are assumed constant.
This study aims to systematically test the repeatability and reproducibility of each
multiparametric MRI measurement, cT1, T2* and PDFF, corresponding to hepatic
fibro-inflammation, iron and fat respectively, across scanner field strength, manufacturer
and model in human participants and phantoms.
