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

Multiple Clinical Trial

— RADIUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05110248
• Other study ID #: 21/WS/0066
• Status: Recruiting
• Start date: November 15, 2021
• Est. completion date: June 15, 2024

Study information

• Verified date: January 2024
• Source: Perspectum
• Contact: Bryn M Horsington
• Phone: 01865 655343
• Email: bryn.horsington[@]perspectum.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple

Locations

Country	Name	City	State
United Kingdom	Gemini One, 5520 John Smith Drive	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Perspectum

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years from study start
Secondary	Sequence and parameter validation	Validation of a list of sequences and parameter details	2 years from study start
Secondary	Assessment of MRI metric repeatability	Assessment of repeatability of the MRI metrics across 2 separate MRI acquisitions on the same scanner using statistical methods	2 years from study start
Secondary	Assessment of MRI metric reproducibility	Assessment of reproducibility of the MRI metrics in the same participants scanned on separate MRI scanners	2 years from study start