MRI Development for Radiotherapy Planning and Delivery in... | NCT04749134

Studies
MRI Development for Radiotherapy Planning and Delivery in Non-Patient Volunteers

NCT04749134

Sponsor

The Christie NHS Foundation Trust

Status

Recruiting

Last Update Posted

Aug 24, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Focus of the Study is MRI Sequence Development

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

Aug 2025

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

Aug 1, 2021Actual

Primary Completion Date

Aug 31, 2028Estimated

Completion Date

Aug 31, 2028Estimated

First Submitted Date

Jan 27, 2021

First Submission Date that Met QC Criteria

Feb 9, 2021

First Posted Date

Feb 11, 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

Aug 19, 2025

Last Update Posted Date

Aug 24, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cynthia Eccles, Head of Radiotherapy Research and Development, The Christie NHS Foundation TrustPrincipal Investigator

Lead Sponsor

The Christie NHS Foundation TrustOTHER

Collaborators

Not provided

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Non-patient volunteers will be scanned on the MR-Linac and MRSIM to facilitate the development, optimisation and validation of MRI protocols at The Christie NHS Foundation Trust.

Detailed Description

Not provided

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

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Developed and optimised of MRI scanning sequences for use in clinical radiotherapy practice in MR guided radiotherapy	on-going development of MRI protocols to be released for clinical use	Through study completion - up to 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing and able to provide written consent
Volunteers must undergo and satisfy MRI safety screening
Volunteers must be ≥ 16 years of age
Participants must agree to registration as a non-patient in CWP (the Trust's Electronic Health Record - EHR- system) and have their MRIs read and reported for incidental findings by a clinical radiologist

Exclusion Criteria:

Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form
Unable to tolerate MRI scan
Known Pregnancy
Known or suspected pathology in body region to be scanned
Member of study team

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Personnel at The Christie NHS Foundation Trust

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Christie NHS FT	Recruiting	Manchester			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