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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple

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 .

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Soubera M Rymell, MSc; Phone Number: 00447313272482; Email: soubera.rymell@perspectum.com
• Study Contact Backup: Name: Rob Suriano, PhD; Email: rob.suriano@perspectum.com

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX4 2LL
      • Recruiting
      • Gemini One, 5520 John Smith Drive
      • Contact: Soubera M Rymell, MSc; Phone Number: 00447919272482; Email: soubera.rymell@perspectum.com
      • Contact: Email: soubera.rymell@perspectum.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Study participants will be adult volunteers aged 18 and over, without a contraindication to magnetic resonance imaging.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of MRI sequences	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.	7 years from study start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sequence and parameter validation	Validation of a list of sequences and parameter details	7 years from study start
Assessment of MRI metric repeatability	Assessment of repeatability of the MRI metrics across 2 separate MRI acquisitions on the same scanner using statistical methods	7 years from study start
Assessment of MRI metric reproducibility	Assessment of reproducibility of the MRI metrics in the same participants scanned on separate MRI scanners	7 years from study start
Assessment of participant comfort during scan	Assessment of participant comfort during different MRI protocols with participant questionnaires.	7 years from study start
Assessment of Standard clinical reference assessment vs MRI	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.	7 years from study start

Collaborators and Investigators

• Sponsor: Perspectum

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): April 30, 2031

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 21/WS/0066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No