Clinical trial NCT05110248: Research and Development of Novel Quantitative Magnetic Resonance Imaging (MRI) Techniques in a Single Scan for Multiple Organ Application
Official title: Research and Development of Novel Quantitative Magnetic Resonance Imaging (MRI) Techniques in a Single Scan for Multiple Organ Application (RADIUS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple
Lead sponsor: Perspectum
Sponsor class: INDUSTRY
First posted: 2021-11-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be adult volunteers aged 18 and over, without a contraindication to magnetic resonance imaging.

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 200 healthy 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 networks, 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 collection of participant's self-reported medical evaluation to assess eligibility according to the inclusion and exclusion criteria.Visit 1 will consist of the collection of basic anthropometric measurements (e.g. height, weight, waist circumference), a medical history, and a MRI scan. Visit 2 will be a repeat of Visit 1.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and older
* Participant is willing and able to give informed consent for participation in the study

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

Primary outcomes:
measure: Development of MRI sequences
timeFrame: 2 years from study start
Secondary outcomes:
measure: Sequence and parameter validation
timeFrame: 2 years from study start
measure: Assessment of MRI metric repeatability
timeFrame: 2 years from study start
measure: Assessment of MRI metric reproducibility
timeFrame: 2 years from study start
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Gemini One, 5520 John Smith Drive
state: Oxfordshire
Study officials:
References: