Multiple
Conditions
Brief summary
Cross-sectional observational study to improve MRI data acquisition techniques by optimising MRI sequences for multiple organs and assessing the repeatability and reproducibility of multiparametric MRI, in healthy volunteers.
Detailed description
This will be a cross-sectional, observational study recruiting up to 600 participants designed at improving MRI data acquisition techniques by optimising MRI sequences and assessing different aspects of the repeatability and reproducibility of multiparametric MRI. Participants will be recruited from Perspectum's own volunteer database, PIC Sites, as well as through advertisements on social media platforms (e.g. Facebook, Instagram), Perspectum's website, as well as through charities. Suitable participants will be invited to attend a screening visit, normally over the telephone, which will involve eConsent process, collection of participant's self-reported medical evaluation to assess eligibility according to the inclusion and exclusion criteria, and demographics. Visit 1 will consist of the collection of basic anthropometric measurements (e.g. height, weight, waist circumference), a medical history, a MRI scan and optional standard clinical reference assessments. Visit 2- 9 will be a repeat of visit 1 tests and an update on the medical history .
Interventions
None listed
Sponsors
Perspectum
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 18 years and older * Participant is willing and able to give informed consent for participation in the study * The participant has a level of English proficiency that allows them to communicate well with the investigator and could comply with study requirements. * The participant is willing and able to undergo MRI scan.
Exclusion criteria
* Any contraindication to magnetic resonance imaging (incl. pregnancy, nonremovable electronic implants including cochlear implants, infusion pumps, and pacemakers, shrapnel injury, severe claustrophobia, allergic reaction to contrast agents) * 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 * The participant may be excluded where body habitus is likely to make MRI or echocardiography/ultrasound uncomfortable or unlikely to yield analysable images, and BMI more than 40-45
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of MRI sequences | 7 years from study start | Development of sequences which will be used to collect good quality data on multiple organs across different MRI scanners and to ensure that desirable images are obtained within reasonable amount of time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sequence and parameter validation | 7 years from study start | Validation of a list of sequences and parameter details |
| Assessment of MRI metric repeatability | 7 years from study start | Assessment of repeatability of the MRI metrics across 2 separate MRI acquisitions on the same scanner using statistical methods |
| Assessment of MRI metric reproducibility | 7 years from study start | Assessment of reproducibility of the MRI metrics in the same participants scanned on separate MRI scanners |
| Assessment of participant comfort during scan | 7 years from study start | Assessment of participant comfort during different MRI protocols with participant questionnaires. |
| Assessment of Standard clinical reference assessment vs MRI | 7 years from study start | Assessment of agreement between MRI derived measures and standard clinical reference assessments (ultrasound, echocardiography), in the same participants, including repeatability for both methods where applicable. |
Countries
United Kingdom
Contacts
CONTACTSoubera M Rymell, MSc
CONTACTRob Suriano, PhD
Outcome results
None listed