BigImAGING: Big Data and Genomic Imaging for the Development of Biomarkers and Nanovector Drugs Innovative for Diagnosis and Therapy of Inflammatory Processes in Dementia
Study Details
Study Description
Brief Summary
The correlation between data obtained by "imaging" in patients with neurodegenerative diseases characterized by inflammation and the presence in the peripheral blood of the same patients "biopsies liquid biopsies" of specific circulating nucleic acids, could enable the development of methods and algorithms capable of identifying novel biomarkers that serve as targets for the development of probes diagnostics and therapeutics. This is the context for the project idea, which is aimed at developing development of a performant multi parameter system capable of identifying novel biomarkers of microglial polarization that can be used for diagnostic and prognostic purposes in determining the staging/progression of neurodegenerative disease
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| neurological disease patients 150 patients with Alzheimer's disease (AD) and Parkinson's disease (PD) for MRI and PET examinations and laboratory medicine |
Radiation: Magnetic Resonance (MR) and positron emission tomograph (PET) imaging analyses
Regarding the neurological MR protocol, the following may be acquired:
3D T1 and T2 high-resolution sequences, acquired in a specific plane and Multiplanar reformation (MPR) reconstructed in the remaining orthogonal planes, for morphological assessment of the different structures under examination;
diffusion sequences for the evaluation of the connection between different areas within a specific organ;
perfusion sequences (ASL, arterial spin labeling) for the evaluation of perfusion without ev mdc administration;
susceptibility sequences for noninvasive assessment of vasculature and deposits of iron.
|
| healthy subjects Healthy subjects |
Radiation: Magnetic Resonance (MR) and positron emission tomograph (PET) imaging analyses
Regarding the neurological MR protocol, the following may be acquired:
3D T1 and T2 high-resolution sequences, acquired in a specific plane and Multiplanar reformation (MPR) reconstructed in the remaining orthogonal planes, for morphological assessment of the different structures under examination;
diffusion sequences for the evaluation of the connection between different areas within a specific organ;
perfusion sequences (ASL, arterial spin labeling) for the evaluation of perfusion without ev mdc administration;
susceptibility sequences for noninvasive assessment of vasculature and deposits of iron.
|
Outcome Measures
Primary Outcome Measures
- Development of a performant multiparametric system capable of identifying novel biomarkers of microglial polarization that can be used for diagnostic and prognostic purposes in determining the staging/progression of neurodegenerative disease [1-36 months]
Collection and processing of multimodal imaging data and biological samples in patients with Dementia; Development of the Informatics Platform to support the interpretation of data in clinical setting
Eligibility Criteria
Criteria
Inclusion Criteria:
All subjects of either sex aged 18 to 85 years who are able to provide voluntary consent, suffering from neurodegenerative diseases (AD and PD)
Exclusion Criteria:
All patients for whom there are contraindications to performing MRI. Also excluded from the study will be subjects who are pregnant, or presumed to be pregnant or undergoing of lactation and subjects with claustrophobia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Synlab SDN | Naples | Italy | 80143 |
Sponsors and Collaborators
- IRCCS SYNLAB SDN
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 6/20