- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07664982
Global Reference Ranges - Mexico (GRR Mexico)
17. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
50
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Healthy volunteers, aged 18 years and over.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Reference intervals for liver cT1
Tidsramme: 24 months
|
Measured using Perspectum's LiverMultiScan
|
24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Reference intervals for liver PDFF, iron and volume
Tidsramme: 24 months
|
Measured using Perspectum's LiverMultiScan
|
24 months
|
|
Reference intervals for pancreas T1 and PDFF
Tidsramme: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for kidney cortical T1 and renal sinus fat volume (RSFV)
Tidsramme: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for measures of body composition
Tidsramme: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for cardiac volumes and function
Tidsramme: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for spleen T1 and volume
Tidsramme: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for lungs fractional change
Tidsramme: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for biliary tree and pancreatic duct metrics
Tidsramme: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
1. august 2029
Studiet fullført (Antatt)
1. august 2029
Datoer for studieregistrering
Først innsendt
12. juni 2026
Først innsendt som oppfylte QC-kriteriene
17. juni 2026
Først lagt ut (Faktiske)
24. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. august 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- EC-554
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