Kinnunen, KM;
Mullin, AP;
Pustina, D;
Turner, EC;
Burton, J;
Gordon, MF;
Scahill, RI;
... Schwarz, AJ; + view all
(2021)
Recommendations to Optimize the Use of Volumetric MRI in Huntington's Disease Clinical Trials.
Frontiers in Neurology
, 12
, Article 712565. 10.3389/fneur.2021.712565.
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Abstract
Volumetric magnetic resonance imaging (vMRI) has been widely studied in Huntington's disease (HD) and is commonly used to assess treatment effects on brain atrophy in interventional trials. Global and regional trajectories of brain atrophy in HD, with early involvement of striatal regions, are becoming increasingly understood. However, there remains heterogeneity in the methods used and a lack of widely-accessible multisite, longitudinal, normative datasets in HD. Consensus for standardized practices for data acquisition, analysis, sharing, and reporting will strengthen the interpretation of vMRI results and facilitate their adoption as part of a pathobiological disease staging system. The Huntington's Disease Regulatory Science Consortium (HD-RSC) currently comprises 37 member organizations and is dedicated to building a regulatory science strategy to expedite the approval of HD therapeutics. Here, we propose four recommendations to address vMRI standardization in HD research: (1) a checklist of standardized practices for the use of vMRI in clinical research and for reporting results; (2) targeted research projects to evaluate advanced vMRI methodologies in HD; (3) the definition of standard MRI-based anatomical boundaries for key brain structures in HD, plus the creation of a standard reference dataset to benchmark vMRI data analysis methods; and (4) broad access to raw images and derived data from both observational studies and interventional trials, coded to protect participant identity. In concert, these recommendations will enable a better understanding of disease progression and increase confidence in the use of vMRI for drug development.
| Type: | Article |
|---|---|
| Title: | Recommendations to Optimize the Use of Volumetric MRI in Huntington's Disease Clinical Trials |
| Location: | Switzerland |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.3389/fneur.2021.712565 |
| Publisher version: | https://doi.org/10.3389/fneur.2021.712565 |
| Language: | English |
| Additional information: | © 2021 Kinnunen, Mullin, Pustina, Turner, Burton, Gordon, Scahill, Gantman, Noble, Romero, Georgiou-Karistianis and Schwarz. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). |
| Keywords: | Huntington's disease, neurodegenerative, clinical trials, biomarkers, volumetric MRI, C-Path |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > Neurodegenerative Diseases |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10138662 |
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