MRinRT: Swansea University and SWWCC Collaboration Study.

NCT07365124 | Not Yet Recruiting

• 1 other identifier: SBU66
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to learn whether using MRI (magnetic resonance imaging) scans to plan radiotherapy is better than using CT (computed tomography) scans alone. The main questions it aims to answer is:

• Can MRI scan images be adjusted to make the tumour and normal tissues easier to see?
• Does adding MRI to a radiotherapy planning CT make the radiotherapy plan more precise?
• Can MRI be used to adjust a radiotherapy plan during a course of treatment to make it more precise, and might that reduce the side effects?
• Are there particular MRI scans that can predict how a tumour will respond to radiotherapy or how likely the patient is to have side effects? This study will assess current MRI scanning procedures and ensure these are adjusted to best suit radiotherapy planning. It will also provide pilot data evaluating:
• MRI-adapted radiotherapy Usually, radiotherapy plans are based on a pre-treatment planning CT scan. Unless an issue is detected the patient would complete their whole course of radiotherapy on this plan. This does not account for changes in position/size/shape of the tumour that occur over the whole treatment course. Clinicians therefore increase the size of the tumour/target to account for these uncertainties, which can increase side effects. This study will assess the potential to reduce side effects from radiotherapy by using repeat MRI scans and replanning during the treatment course (MRI-adaptive radiotherapy).
• Imaging biomarkers MRI sequences can be used to predict response to radiotherapy or chance of developing side effects. This study will identify potential MRI sequences that may be used as imaging biomarkers, to guide the development of future clinical trials.

Conditions

Carcinoma; Glioblastoma; Radiotherapy; MRI; MRI-guided Adaptive Radiotherapy; MRI Scanner Configuration; MRI Image Enhancement; Oesophageal Carcinoma; Pancreas Carcinoma; Gastric Cancer; Brain (Nervous System) Cancers

Keywords

MRI; Radiotherapy; MRI adaptive radiotherapy; MRI Imaging Biomarker

Outcome Measures

Primary Outcomes (7)

• Optimisation of MRI images 1

  Participant acceptability with average rating of 4 or higher on the Participant Questionnaire MRI Section Q1 and Q2

  From enrolment to analysis, on average 4-6 weeks

• Optimisation of MRI images 2

  Physics team expert opinion that the sequence is optimised, assessed as per the Physics Team Questionnaire by 2 independent expert medical physicists

  From enrolment to analysis, on average 4-6 weeks

• Optimisation of MRI images 3

  Visual grading characteristics analysis rating 4 or higher and deemed acceptable for clinical purposes by 3 independent clinicians as per the Image Properties Data Collection Form

  From enrolment to analysis, on average 4-6 weeks

• Assess the effect of MRI-CT Integration in the radiotherapy pathway 1

  This will involve analysis of radiotherapy plans produced with and without an MRI scan at the time of the CT planning scan, to include: Dosimetry Comparison (evaluation of differences in dose distributions delivered to target volumes and OARs);

  From enrolment to analysis, on average 4-6 weeks

• Assess the effect of MRI-CT Integration in the radiotherapy pathway 2

  This will involve analysis of radiotherapy plans produced with and without an MRI scan at the time of the CT planning scan, to include: Volumetric Comparison (assessment of differences in target and OAR delineation volumes);

  From enrolment to analysis, on average 4-6 weeks

• Assess the effect of MRI-CT Integration in the radiotherapy pathway 3

  This will involve analysis of radiotherapy plans produced with and without an MRI scan at the time of the CT planning scan, to include: Qualitative Confidence Assessment (expert ratings of confidence in contouring accuracy rated on a 5-point Likert scale as per Outlining Clinician Questionnaire)

  From enrolment to analysis, on average 4-6 weeks

• Assess the effect of MRI-CT Integration in the radiotherapy pathway 4

  This will involve analysis of radiotherapy plans produced with and without an MRI scan at the time of the CT planning scan, to include: Prediction of change in toxicity using normal tissue complication probability modelling

  From enrolment to analysis, on average 4-6 weeks

Secondary Outcomes (3)

• MRI-Adapted Radiotherapy 1

  From enrolment to analysis, on average 4-6 weeks

• MRI-Adapted Radiotherapy 2

  From enrolment to analysis, on average 4-6 weeks

• MRI-Adapted Radiotherapy 3

  From enrolment to analysis, on average 4-6 weeks

Other Outcomes (1)

• Quantitative Imaging Biomarkers

  From enrolment until a maximum of 2 years after completing treatment

Study Arms (2)

Healthy Volunteer

Volunteers with no history of any medical issue which may affect the scan interpretation and who are eligible for MRI scanning

Other: MRI

Patient

Patients with the tumour of interest who are due to undergo radiotherapy and are eligible for MRI scanning

Other: MRI

Interventions

MRI OTHER

This is an observational study with no interventions. Participants will undergo MRI scanning for research purposes and radiotherapy treatment will be delivered as per standard of care for the participants tumour type.

Healthy Volunteer; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants for this study will be: 1. healthy volunteers from Swansea Bay University Health Board or Swansea University 2. patients with cancer who are due to undergo radiotherapy at Swansea Bay University Health Board

You may qualify if:

• Free from medical conditions that could confound imaging or study results
• Eligible for MRI
• Confirmed diagnosis of invasive carcinoma at the relevant tumour/target sites listed in this protocol
• Scheduled to receive radiotherapy to the target site
• ECOG performance status of 0-2
• Eligible for MRI (determined through MRI safety screening)

You may not qualify if:

• Presence of medical conditions that may interfere with study outcomes or data interpretation
• Use of regular medications that could affect imaging results or safety
• Any contraindications to MRI scanning, including but not limited to claustrophobia, reduced thermal regulatory capabilities, MR Unsafe implants and foreign bodies.

Sponsors & Collaborators

• Swansea Bay University Health Board: lead
• Swansea University: collaborator

Study Sites (1)

Swansea Bay University Health Board

Swansea, United Kingdom

Location

Related Publications (4)

• Keall P, Poulsen P, Booth JT. See, Think, and Act: Real-Time Adaptive Radiotherapy. Semin Radiat Oncol. 2019 Jul;29(3):228-235. doi: 10.1016/j.semradonc.2019.02.005.

  PMID: 31027640 BACKGROUND

• Hunt A, Hansen VN, Oelfke U, Nill S, Hafeez S. Adaptive Radiotherapy Enabled by MRI Guidance. Clin Oncol (R Coll Radiol). 2018 Nov;30(11):711-719. doi: 10.1016/j.clon.2018.08.001. Epub 2018 Sep 7.

  PMID: 30201276 BACKGROUND

• Bakke KM, Hole KH, Dueland S, Groholt KK, Flatmark K, Ree AH, Seierstad T, Redalen KR. Diffusion-weighted magnetic resonance imaging of rectal cancer: tumour volume and perfusion fraction predict chemoradiotherapy response and survival. Acta Oncol. 2017 Jun;56(6):813-818. doi: 10.1080/0284186X.2017.1287951. Epub 2017 Feb 17.

  PMID: 28464745 BACKGROUND

• Huddart R et al, Protocol for Development of daily online magnetic resonance imaging for magnetic resonance image guided radiotherapy, IRAS ID 208449, version 6.0 22/2/2024

  BACKGROUND

MeSH Terms

Conditions

Carcinoma; Glioblastoma; Esophageal Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Neurologic Manifestations; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Stomach Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clair Brunner, MB BChir BA MRCP FRCR PGCert

  Swansea Bay University Health Board

  PRINCIPAL INVESTIGATOR

• Jonathan Phillips, PhD MSci MSc PGDip PGCert

  Swansea Bay University Health Board and Swansea University

  PRINCIPAL INVESTIGATOR

• Owen Nicholas, MBBS MRCP MD

  Swansea Bay University Health Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Owen Nicholas, MBBS FRCR MD

CONTACT

01792205666; owen.nicholas@wales.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 26, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2032
• Last Updated: April 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)