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

Официальное название

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

Обзор

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.

Подробное описание

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 .

Первичные конечные точки

• Development of MRI sequences [Срок оценки: 7 years from study start]

Вторичные конечные точки (5)

• Sequence and parameter validation [Срок оценки: 7 years from study start]
• Assessment of MRI metric repeatability [Срок оценки: 7 years from study start]
• Assessment of MRI metric reproducibility [Срок оценки: 7 years from study start]
• Assessment of participant comfort during scan [Срок оценки: 7 years from study start]
• Assessment of Standard clinical reference assessment vs MRI [Срок оценки: 7 years from study start]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Великобритания · 1 центр

• Gemini One, 5520 John Smith Drive — Oxford

Идентификаторы

NCT: NCT05110248 · 21/WS/0066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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