Research and Development of Novel Quantitative Magnetic R... | NCT05110248

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

NCT05110248

Sponsor

Perspectum

Status

Recruiting

Last Update Posted

May 20, 2026Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Multiple

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2021Actual

Primary Completion Date

Mar 1, 2031Estimated

Completion Date

Apr 30, 2031Estimated

First Submitted Date

Oct 26, 2021

First Submission Date that Met QC Criteria

Oct 26, 2021

First Posted Date

Nov 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2026

Last Update Posted Date

May 20, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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 .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Soubera M Rymell, MSc	Contact	00447313272482		soubera.rymell@perspectum.com
Rob Suriano, PhD	Contact			rob.suriano@perspectum.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gemini One, 5520 John Smith Drive	Recruiting	Oxford	Oxfordshire	OX4 2LL	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided