Twins MR Imaging Study

Aging Clinical Trial

Official title:

Characterising Biomarkers of Disease and Ageing in Twins Using Magnetic Resonance Imaging

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06014567
• Other study ID #: 322446
• Status: Enrolling by invitation
• Start date: December 19, 2023
• Est. completion date: March 2028

Study information

• Verified date: July 2023
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to create a comprehensive Magnetic Resonance Imaging data resource in twins aged 18 years and older. The data will be used alone or in conjunction with existing data to explore organ-specific ageing and twin-pair differences related to ageing and disease.

Description:

BACKGROUND Diverse interactions between environmental, genetic, and epigenetic factors shape individual paths of ageing and disease. In young adulthood, twins are highly similar in most organ structures, but their similarity decreases over time as they are progressively exposed to different environments. Twin studies provide an ideal way to investigate how the body ages and how age-related diseases (such as Alzheimer's disease, heart failure, fatty liver disease, and cancer) develop. Magnetic Resonance Imaging (MRI) is a type of scan that produces detailed images of the inside of the body. MRI enables non-invasive and safe visualisation of age and disease-related changes in the body, often long before clinical symptoms are perceived. MRI-derived biological features/biomarkers can be used to understand the influence of environmental exposures on ageing and disease.

PARTICIPANTS 2500 adult (age 18 and older) volunteers of TwinsUK, the UK's largest adult twin Biobank and the most clinically detailed globally, will be invited to participate. Interested individuals will complete screening to confirm study eligibility and their safety for MRI scanning. Eligible participants will complete informed consent prior to undertaking research MRI scans of their brain, spine, heart, abdomen and parts of their skeleton and muscles. 350 twins with differences in their data will be invited to repeat the MRI scans about two years later to explore longitudinal multi-organ imaging correlates of key environmental exposures based on cross-sectional signals and existing literature.

PROCEDURES Two 45-minute MRI scans of (1) the head and spine and (2) the abdomen to the upper thigh.

OUTCOMES Imaging-derived measures of morphology and function of the brain, spine, abdominal organs and musculoskeletal tissue. These measures will be used to identify twin pair differences related to ageing and disease. A comprehensive repository of MRI data will be created using protocols harmonised with the UK biobank. This will facilitate subsequent linkage with concurrently acquired samples and historic exposome data in longitudinal twin cohort.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2500
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Identical or non-identical twins

• Gender: Male or Female

• Age: 18 years or above at the time of recruitment

• Must be able to understand the study information and provide informed consent

• Participation in the TwinsUK Biobank

Exclusion Criteria:

• Pregnancy

• Unable to tolerate MRI Procedures, e.g., claustrophobia, severe anxiety

• Contraindication to MRI Scanning, e.g., presence of non-MR conditional implants

• Any additional condition declared voluntarily by the participant that the principal investigator (PI) deems likely to affect the study's outcome.

Related Conditions & MeSH terms

• Aging

Intervention

Procedure:
• Magnetic Resonance Imaging
A single (=45 minutes) brain MRI will include T1w and T2w imaging to assess the morphology and structure of the brain, as well as inflammatory processes. Diffusion-weighted imaging will be used to gain information about internal brain connectivity related to brain functions. MRI, MR angiography (MRA) and fMRI pulse sequences will also be acquired to detect vascular pathologies and brain lesions. T2w morphological images of the whole spine will also be obtained. A single (=45 minutes) MR imaging investigation to include cardiovascular, abdominal, and musculoskeletal regions. MRI will be performed to assess the structure and function of these body regions and organs, including functional imaging of the heart. These investigations will include T1w and T2w imaging to assess morphology and structure, mapping studies of T1, T2 and T2*, perfusion imaging and cine imaging to assess the heart dynamically.

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Cole JH, Poudel RPK, Tsagkrasoulis D, Caan MWA, Steves C, Spector TD, Montana G. Predicting brain age with deep learning from raw imaging data results in a reliable and heritable biomarker. Neuroimage. 2017 Dec;163:115-124. doi: 10.1016/j.neuroimage.2017.07.059. Epub 2017 Jul 29. — View Citation

Linge J, Borga M, West J, Tuthill T, Miller MR, Dumitriu A, Thomas EL, Romu T, Tunon P, Bell JD, Dahlqvist Leinhard O. Body Composition Profiling in the UK Biobank Imaging Study. Obesity (Silver Spring). 2018 Nov;26(11):1785-1795. doi: 10.1002/oby.22210. Epub 2018 May 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BrainAGE score	BrainAGE will be calculated using MRI-derived phenotypes of brain volumetric changes (Cole et al, 2017).	At time of scan (duration 45 mins)
Primary	BodyAGE score	BodyAGE will be calculated using MRI-derived phenotypes of organ and tissue changes in the heart, liver, pancreas, kidneys, spine and muscle (Linge et al, 2018).	At time of scan (duration 45 mins)