Healthy Adult ParticipantsGRR MexicoNCT07664982
Global Reference Ranges - Mexico
An observational study of Healthy Adult Participants, run by Perspectum.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers, aged 18 years and over.
Who may be able to join
- 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
Who cannot join
- History of cardiovascular disease as follows:
- Myocardial infarction
- Heart failure
- Cardiomyopathy
- Stroke
- Hospital admission/discharge for unstable angina
Show all 13Show fewer
- 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
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Healthy Adult Participants
What is being measured
The primary outcome is the main question the study is designed to answer.
Reference intervals for liver cT1
Measured using Perspectum's LiverMultiScan
Measured: 24 months
Secondary outcomes (8)
Reference intervals for liver PDFF, iron and volume
Measured using Perspectum's LiverMultiScan
Measured: 24 months
Reference intervals for pancreas T1 and PDFF
Measured using Perspectum's CoverScan
Measured: 24 months
Reference intervals for kidney cortical T1 and renal sinus fat volume (RSFV)
Measured using Perspectum's CoverScan
Measured: 24 months
Reference intervals for measures of body composition
Measured using Perspectum's CoverScan
Measured: 24 months
Reference intervals for cardiac volumes and function
Measured using Perspectum's CoverScan
Measured: 24 months
Reference intervals for spleen T1 and volume
Measured using Perspectum's CoverScan
Measured: 24 months
Reference intervals for lungs fractional change
Measured using Perspectum's CoverScan
Measured: 24 months
Reference intervals for biliary tree and pancreatic duct metrics
Measured using Perspectum's CoverScan
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perspectum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664982
- Sponsor's protocol ID
- EC-554
- Acronym
- GRR Mexico
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Reference Ranges (GRR) for Magnetic Resonance Imaging of Intra-abdominal Organs in Healthy Adults From Different Ethnic Groups - Mexico
- ClinicalTrials.gov ID
- NCT07664982
- Acronym / sponsor ID
- GRR Mexico / EC-554
- Conditions
- Healthy Adult Participants
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- PerspectumIndustry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers, aged 18 years and over.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- History of cardiovascular disease as follows:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reference intervals for liver cT1
Time frame: 24 months
Measured using Perspectum's LiverMultiScan
8 secondary outcomes
Reference intervals for liver PDFF, iron and volume
Time frame: 24 months
Reference intervals for pancreas T1 and PDFF
Time frame: 24 months
Reference intervals for kidney cortical T1 and renal sinus fat volume (RSFV)
Time frame: 24 months
Reference intervals for measures of body composition
Time frame: 24 months
Reference intervals for cardiac volumes and function
Time frame: 24 months
Reference intervals for spleen T1 and volume
Time frame: 24 months
Reference intervals for lungs fractional change
Time frame: 24 months
Reference intervals for biliary tree and pancreatic duct metrics
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adult Participants, run by Perspectum.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reference intervals for liver cT1 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.