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Global Reference Ranges - Mexico (GRR Mexico)

17 augusti 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

50

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Healthy volunteers, aged 18 years and over.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Reference intervals for liver cT1
Tidsram: 24 months
Measured using Perspectum's LiverMultiScan
24 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Reference intervals for liver PDFF, iron and volume
Tidsram: 24 months
Measured using Perspectum's LiverMultiScan
24 months
Reference intervals for pancreas T1 and PDFF
Tidsram: 24 months
Measured using Perspectum's CoverScan
24 months
Reference intervals for kidney cortical T1 and renal sinus fat volume (RSFV)
Tidsram: 24 months
Measured using Perspectum's CoverScan
24 months
Reference intervals for measures of body composition
Tidsram: 24 months
Measured using Perspectum's CoverScan
24 months
Reference intervals for cardiac volumes and function
Tidsram: 24 months
Measured using Perspectum's CoverScan
24 months
Reference intervals for spleen T1 and volume
Tidsram: 24 months
Measured using Perspectum's CoverScan
24 months
Reference intervals for lungs fractional change
Tidsram: 24 months
Measured using Perspectum's CoverScan
24 months
Reference intervals for biliary tree and pancreatic duct metrics
Tidsram: 24 months
Measured using Perspectum's CoverScan
24 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

1 augusti 2029

Avslutad studie (Beräknad)

1 augusti 2029

Studieregistreringsdatum

Först inskickad

12 juni 2026

Först inskickad som uppfyllde QC-kriterierna

17 juni 2026

Första postat (Faktisk)

24 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 augusti 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • EC-554

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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