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Recruiting NCT05110248

Research and Development of Novel Quantitative Magnetic Resonance Imaging (MRI) Techniques in a Single Scan for Multiple Organ Application

— Observational Multiple

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Research and Development of Novel Quantitative Magnetic Resonance Imaging (MRI) Techniques in a Single Scan for Multiple Organ Application (RADIUS)

Overview

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 .

Primary outcome measures

  • Development of MRI sequences [Time frame: 7 years from study start]
Secondary outcome measures (5)
  • Sequence and parameter validation [Time frame: 7 years from study start]
  • Assessment of MRI metric repeatability [Time frame: 7 years from study start]
  • Assessment of MRI metric reproducibility [Time frame: 7 years from study start]
  • Assessment of participant comfort during scan [Time frame: 7 years from study start]
  • Assessment of Standard clinical reference assessment vs MRI [Time frame: 7 years from study start]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

United Kingdom · 1 center
  • Gemini One, 5520 John Smith Drive — Oxford

Identifiers

NCT: NCT05110248 · 21/WS/0066

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗