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Trial Ready Small Vessel MRI Markers: Proof of Concept

Descrizione del progetto

Un software consente di applicare marcatori RM avanzati a immagini cerebrali provenienti da dispositivi RM standard

La malattia cerebrale dei piccoli vasi (SVD, Small Vessel Disease), come suggerisce il nome, è caratterizzata da significative anomalie strutturali e funzionali del microcircolo cerebrale. È molto comune nelle persone anziane ed è uno dei principali responsabili dell’ictus e dell’emorragia cerebrale. La SVD è anche una delle principali cause di compromissione cognitiva e demenza. Al momento è difficile visualizzare la patologia in vivo fino a quando non avviene il danno e non esistono farmaci disponibili per la prevenzione o il trattamento. Il progetto SELMA ha sviluppato tecniche per visualizzare questi piccoli vasi in potenti macchine RM a 7-Tesla (7T). Il progetto mira a trasferire le sequenze di impulsi RM 7T ai comuni scanner RM 3T tramite strumenti di analisi automatizzata per supportare il loro uso ubiquitario e sviluppare efficaci trattamenti SVD attraverso robusti biomarcatori.

Obiettivo

Problem:
Cerebral small vessel disease (SVD) is a hallmark of serious brain diseases such as acute stroke and dementia. It has a major impact on society, since it affects quality of life of many ageing individuals, and increasingly challenges the healthcare resources. Current image-based biomarkers do not reflect SVD itself, but rather macroscopic, irreversible brain damage, secondary to the abnormalities of the small vessels. This greatly hampers development of new drugs as clinical trials lack effective biomarkers directly reflecting SVD.
Solution:
The SmallVesselMRI ERC project (337333), yielded 7T MRI methods with the potential to offer a paradigm shift in SVD research. We have developed new MRI measures that, for the first time, allow non-invasive assessment of the condition of the small vessels themselves, including blood flow velocity pulsation in small perforating vessels, which informs on vessel stiffness. The current proof-of-concept project ‘trial-ready Small vEsseL MRI MArkers (SELMA) aims to make these novel promising vascular parameters ready for use in phase II/III clinical trials. Our ambition is to bridge the gap between high end imaging research platforms and widespread clinical MRI, in order to enable drug-target engagement studies in clinical trials for newly developed drugs.
SELMA will:
1) Port the small-vessel 7T MRI pulse sequences to clinically ubiquitous 3T MRI scanners. 2) Develop a software tool that can provide robust, automated data analysis. 3) Determine the reproducibility of the SELMA biomarkers in a group of 35 healthy individuals with scan-rescan experiments. 4) Provide clinical proof of concept by a pilot study in 15 patients with SVD, measuring the vascular parameters before and after administration of a pharmaceutical agent. Using results of our proof of concept study, we will develop a business plan to approach the pharmaceutical industry to change the paradigm in drug development for SVD treatment.

Meccanismo di finanziamento

ERC-POC - Proof of Concept Grant

Istituzione ospitante

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Contribution nette de l'UE
€ 149 979,00
Indirizzo
HEIDELBERGLAAN 100
3584 CX Utrecht
Paesi Bassi

Mostra sulla mappa

Regione
West-Nederland Utrecht Utrecht
Tipo di attività
Higher or Secondary Education Establishments
Collegamenti
Costo totale
€ 149 979,00

Beneficiari (1)