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:
1. 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). 2. 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.
The study will be undertaken at SBUHB, lasting 4 years, and involving ≤15 healthy volunteers and ≤150 patients.
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
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.
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
Cohort
Prospective
MRI
Other interventionThis 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.
Optimisation of MRI images 1
Participant acceptability with average rating of 4 or higher on the Participant Questionnaire MRI Section Q1 and Q2
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
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
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);
MRI-Adapted Radiotherapy 1
This will involve analysis of radiotherapy plans produced following an MRI scan during radiotherapy treatment and compared to the original radiotherapy plan, to include: Dosimetry Comparison (evaluation of differences in dose distributions delivered to target volumes and OARs);
MRI-Adapted Radiotherapy 2
This will involve analysis of radiotherapy plans produced following an MRI scan during radiotherapy treatment and compared to the original radiotherapy plan, to include: Volumetric Comparison (assessment of differences in target and OAR delineation volumes);
MRI-Adapted Radiotherapy 3
This will involve analysis of radiotherapy plans produced following an MRI scan during radiotherapy treatment and compared to the original radiotherapy plan, to include: Prediction of change in toxicity using normal tissue complication probability modelling
Quantitative Imaging Biomarkers
This exploratory end point will involve analysis of the feasibility, sensitivity and specificity of structural and functional MRI sequences identified as potential imaging biomarkers. This will include correlation of the potential imaging biomarker with patient outcomes including histological tumour regression grading for patients who go on to have surgery, disease progression on other radiological imaging (as per RECIST) and with CTCAE toxicity grading following radiotherapy treatment and with survival metrics e.g. progression free survival, cancer specific survival, overall survival.
Click on the lead sponsor to view all of their trials.
Swansea Bay University Health Board
Lead sponsor
Swansea University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
