Descripción del proyecto
Una solución revolucionaria para las hepatopatías
Las enfermedades hepáticas crónicas, o hepatopatías crónicas, son conocidas desde hace tiempo como asesinas silenciosas, que acechan sin ser detectadas hasta alcanzar estadios intratables. Entre estas dolencias, la enfermedad del hígado graso no alcohólico y su subtipo, la esteatohepatitis no alcohólica, son las principales responsables. Si no se tratan, estas afecciones pueden evolucionar a cirrosis e insuficiencia hepática, que representan una crisis sanitaria mundial. Sin embargo, el método existente para diagnosticar y estadificar las hepatopatías, a saber, la biopsia hepática, es caro, invasivo y arriesgado. En el proyecto RADIcAL, financiado con fondos europeos, se pretende transformar el panorama del diagnóstico y el seguimiento del tratamiento de las hepatopatías. En concreto, se someterá a ensayo un avanzado sistema informatizado de resonancia magnética cuantitativa y no invasiva. Esta herramienta muestra una notable precisión diagnóstica en la evaluación precoz de hepatopatías y puede utilizarse para la estadificación de pacientes.
Objetivo
Chronic liver diseases are called 'silent killers', as clinical symptoms only surface at late stages of the disease, when it is not treatable. Non-alcoholic fatty liver disease (NAFLD), a condition defined by fat accumulation in the liver, and its sub-type non-alcoholic steatohepatitis (NASH) are the major forms of liver disease. Untreated NAFLD/NASH can lead to cirrhosis and to liver failure. 450 million people worldwide suffer from fatty liver disease, which carries several health risks, and causes a huge socio-economic burden. At present, the only way of diagnosing and staging disease is with liver biopsy, which is costly, invasive, and carries some risk. Thus, clinicians are reluctant to use it for people suspected of having NAFLD/NASH. In addition, invasive biopsy is not optimal for serial assessment (e.g. monitoring transplant population for signs of liver rejection). Therefore, there is a lack of an accurate and non-invasive method of assessing liver disease and enabling treatment monitoring.
Perspectum Diagnostics Ltd (PD) has developed LiverMultiScan, a novel, non-invasive, quantitative Magnetic Resonance Imaging software tool that displays high diagnostic accuracy for the early assessment of liver disease, and can be used for patient stratification. It has recently obtained regulatory clearance, but it requires additional clinical validation to assure its broad market acceptance and reimbursement. Thus, RADIcAL entails two clinical trials: a) a multi-centre randomised health economic study to validate the cost-effectiveness and added value of LiverMultiScan compared to the standard care pathway for chronic liver disease; and (b) a prospective clinical trial to demonstrate the high sensitivity and specificity of LiverMultiScan as a medical support tool for stratifying patients at high risk of liver transplant rejection.
Ámbito científico
- medical and health sciencesclinical medicinesurgery
- medical and health sciencesclinical medicineendocrinologydiabetes
- medical and health sciencesclinical medicinehepatology
- engineering and technologymedical engineeringdiagnostic imagingmagnetic resonance imaging
- medical and health scienceshealth sciencesnutritionobesity
Programa(s)
Tema(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-SMEINST-2-2015
Régimen de financiación
SME-2 - SME instrument phase 2Coordinador
OX4 2LL Oxford
Reino Unido
Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención.