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Big Data and Genomic Imaging for the Development of Biomarkers and Nanovector Drugs Innovative for Diagnosis and Therapy of Inflammatory Processes in Dementia

Big Data and Genomic Imaging for the Development of Biomarkers and Nanovector Drugs Innovative for Diagnosis and Therapy of Inflammatory Processes in Dementia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05761535
Acronym
BigImAGING
Enrollment
137
Registered
2023-03-09
Start date
2020-06-17
Completion date
2023-06-30
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodegenerative Diseases

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

Interventions

RADIATIONMagnetic 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.

Sponsors

IRCCS SYNLAB SDN
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 disease1-36 monthsCollection 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026