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Young boy laying down and looking at his mom, who is standing next to him in a yellow shirt, while two doctors prepare him for an MRI scan.

MRI/MRS as Non-Invasive Biomarker to Quantitatively Measure Disease Progression and Drug Efficacy

ImagingNMD is closely working with pharmaceutical companies to facilitate clinical trials of new drugs for various muscular dystrophies. We provide professional management of all MR related study activities and deliver precise MR outcome measurements. We are specialized in logistics of scan handling and tracking with extensive experience in skeletal and cardiac muscle imaging (MRI), spectroscopy (MRS), and the development of MRI/MRS biomarkers.

Our team are experts in acquisition and analysis of quantitative MRS and MRI outcomes, including muscle fat fraction (MRS and Dixon imaging), transverse relaxation time (T2), and cross-sectional area. Customized, advanced automatic analysis techniques are combined with expert supervision to maximize the precision of outcome measures and study power.

ImagingNMD’s Capabilities

Why Choose ImagingNMD UF as a Global Partner

We have an experienced team with a wealth of knowledge, experience with clinical trials, and collaboration with established MR sites. ImagingNMD is a world leader in developing and validating MR imaging biomarkers in Duchenne Muscular Dystrophy as well as Beckers and Limb Girdle Muscular Dystrophy.

Multiple MR experts with >80 years of combined experience

MR facilities chosen based on ability to successfully image children aged 4-18 years without sedation, following standardized procedures

Contracts with MR facilities strategically located in North America and Europe

Training and certification of MR sites and personnel to ensure optimal scanner performance and high-quality data collection

Provision of study materials including certified phantoms

Technical support to MR sites and advise on the choice of MRI/MRS metrics

Standardized SOPs and development of study specific MOPs and Forms

Centralized MR data reading, processing and management

MR site monitoring (remote and on-site) and MR data quality assurance

MRI

MRI is a non-invasive imaging method that provides detailed information about muscle structure and composition. MRI scanners generate images using magnetic fields and do not use ionizing radiation. Quantitative imaging biomarkers can accurately measure changes in muscle pathology.

Data showing Duchenne muscular dystrophy progression

MRS

MRS uses the same scanner and provides information about the chemical composition of tissues, including the fatty replacement of muscle, a valuable marker of disease progression in neuromuscular diseases.

Data showing Duchenne muscular dystrophy progression

Technical Expertise

Extensive Clinical Trial Experience with MRI/MRS Data as Endpoints

MRI/MRS biomarkers provide highly sensitive measures of muscle pathology and are valuable in the context of clinical trials.

As treatment options for neuromuscular diseases continue to expand, the need for imaging biomarkers in clinical trials is greater than ever. The ImagingNMD team at the University of Florida has the expertise and experience to meet all aspects of clinical trial needs for MR imaging. Our services range from expert consultation on protocol design, to implementation and management of data collection at specialized sites throughout the world, and refined quality control and analysis methods using custom proven algorithms for reliable and precise results.

Data Sharing Capabilities

Data Sharing

ImagingNMD has grown into one of the most comprehensive natural history studies in DMD and BMD and serves as a unique and valuable resource for muscular dystrophy communities. ImagingNMD shares MRI/MR derived data with accompanying demographic and functional information to facilitate the design of clinical trials. Raw data are collected from many different sources: Magnetic resonance imaging (MRI) and spectroscopy (MRS), genetic diagnoses, demographics, medical and medication history, strength and functional assessments, and biological samples. A summary of the available elements is provided in the Data Dictionary and a description can be found under the Cohort Demographics section.

Restricted Access

This data set will include de-identified DICOM image and spectroscopy files as well as tabular data files containing age, height, weight, functional assessment final scores, strength assessment scores, corticosteroid use status, ambulation status, and other information that can be included without compromising subject confidentiality. In accordance with our informed consent form, researchers will be required to apply for access to the data set by submitting the following information, which will be reviewed by an Executive Committee: Researcher name(s), institutional affiliation(s), and a brief proposal outlining how the data will be used. If shared data are used in subsequent publications the original funding source (AR056973) and the ImagingDMD network will need to be acknowledged and published methodology developed during the course of the study cited, as appropriate.