- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07664982
Global Reference Ranges - Mexico (GRR Mexico)
17 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
50
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Healthy volunteers, aged 18 years and over.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reference intervals for liver cT1
Délai: 24 months
|
Measured using Perspectum's LiverMultiScan
|
24 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reference intervals for liver PDFF, iron and volume
Délai: 24 months
|
Measured using Perspectum's LiverMultiScan
|
24 months
|
|
Reference intervals for pancreas T1 and PDFF
Délai: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for kidney cortical T1 and renal sinus fat volume (RSFV)
Délai: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for measures of body composition
Délai: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for cardiac volumes and function
Délai: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for spleen T1 and volume
Délai: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for lungs fractional change
Délai: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for biliary tree and pancreatic duct metrics
Délai: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
1 août 2029
Achèvement de l'étude (Estimé)
1 août 2029
Dates d'inscription aux études
Première soumission
12 juin 2026
Première soumission répondant aux critères de contrôle qualité
17 juin 2026
Première publication (Réel)
24 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 août 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- EC-554
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .