- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07664982
Global Reference Ranges - Mexico (GRR Mexico)
17 de agosto de 2026 actualizado por: Perspectum
Global Reference Ranges (GRR) for Magnetic Resonance Imaging of Intra-abdominal Organs in Healthy Adults From Different Ethnic Groups - Mexico
The investigators aim to undertake the Global Reference Range Study (GRR) to establish a set of healthy adult reference values for measures of fibroinflammation, fat and size/volumes for the liver, and other abdominal and thoracic organs to assess, compare, and if necessary, propose ethnicity specific reference ranges for these measurements.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
The increasing rates of global obesity have been substantial in the adult population.
Obesity is associated with metabolic syndromes and poses a major risk factor for diabetes, cardiovascular disease (CVD), and premature mortality.
There has been a recent change in the definition and diagnosis of (clinical) obesity which emphasises that to identify early and effective treatments to prevent adverse clinical outcomes, it is essential to evaluate the health across multiple organs in the body.
The advancements in multiorgan imaging to evaluate organ health is key in guiding risk stratification, diagnosis of organ-specific abnormalities and the development of targeted treatment strategies, and in recent years the indications for magnetic resonance imaging (MRI) have significantly expanded.
In chronic liver diseases, the investigators have previously shown that multiparametric MRI of the liver has prognostic capabilities, and in the detection of treatment response.
The investigator's multiorgan MRI method is a non-contrast MRI acquisition that allows for the measurement of fibro-inflammation and fat in and around the abdominal and thoracic organs, as well as the characterisation of organ size and volume and, specific to the heart, cardiac function in a single MRI scan.
This approach has revealed persistence of multiorgan abnormalities across a range of disease indications including with people living with type 2 diabetes and lasting effects following COVID-19 infection.
Many of the approaches for organ quantification have been adopted into routine clinical practice, for example liver MRI has been included in clinical guidelines for the assessment of MASH.
However, as for all imaging modalities, being able to distinguish between healthy and diseased organs is critical - which relies on the availability of robust healthy reference ranges.
Current MRI reference values have been predominantly based on white population datasets, whilst very limited values from other ethnic populations exist.
There are well-known ethnic variations in healthy cardiovascular phenotypes based on echocardiographic studies.
Consequently, there is a need to establish the healthy reference ranges across a range of ethnicities stratified against biological sex and age to allow for global comparison of MRI measures.
Tipo de estudio
De observación
Inscripción (Estimado)
50
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
Healthy volunteers, aged 18 years and over.
Descripción
Inclusion Criteria:
- Male or female at least 18 years of age
- Self-reported healthy
- Willing and able to give informed consent for participation in the study
- Willing and able to undergo an MRI
Exclusion Criteria:
History of cardiovascular disease as follows:
- Myocardial infarction
- Heart failure
- Cardiomyopathy
- Stroke
- Hospital admission/discharge for unstable angina
- Heart surgery
- Unstable angina
- Transient ischemic attack
- Presence of CVD risk factors such as hypertension, hyperlipidaemia, Type 2 diabetes, BMI > 30 kg/m2, smoker (current/ex-smoker)
- History of non-cardiac diseases related to the lungs, liver, kidneys, pancreas or spleen judged by the study investigator as therefore unsuitable to participate in the study
- The participant may not enter the study if they have any contraindication to magnetic resonance imaging (standard MRI exclusion criteria including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia)
- Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reference intervals for liver cT1
Periodo de tiempo: 24 months
|
Measured using Perspectum's LiverMultiScan
|
24 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reference intervals for liver PDFF, iron and volume
Periodo de tiempo: 24 months
|
Measured using Perspectum's LiverMultiScan
|
24 months
|
|
Reference intervals for pancreas T1 and PDFF
Periodo de tiempo: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for kidney cortical T1 and renal sinus fat volume (RSFV)
Periodo de tiempo: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for measures of body composition
Periodo de tiempo: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for cardiac volumes and function
Periodo de tiempo: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for spleen T1 and volume
Periodo de tiempo: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for lungs fractional change
Periodo de tiempo: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for biliary tree and pancreatic duct metrics
Periodo de tiempo: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de agosto de 2029
Finalización del estudio (Estimado)
1 de agosto de 2029
Fechas de registro del estudio
Enviado por primera vez
12 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de junio de 2026
Publicado por primera vez (Actual)
24 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de agosto de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- EC-554
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .