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

Recruiting

• Conditions: Multiple

• Registration Number: NCT05110248
• Lead Sponsor: Perspectum

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.

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-05
• Study Start: 2021-11-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of MRI sequences	2 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 Outcome Measures

Name	Time	Method
Assessment of MRI metric repeatability	2 years from study start	Assessment of repeatability of the MRI metrics across 2 separate MRI acquisitions on the same scanner using statistical methods
Sequence and parameter validation	2 years from study start	Validation of a list of sequences and parameter details
Assessment of MRI metric reproducibility	2 years from study start	Assessment of reproducibility of the MRI metrics in the same participants scanned on separate MRI scanners

Trial Locations

Locations (1)

Gemini One, 5520 John Smith Drive; 🇬🇧 Oxford, Oxfordshire, United Kingdom