About this trial
In radiotherapy high-tech scans with x-rays (CT scans) are taken before and during treatment to locate the tumour and ensure the radiation is hitting the target.
These x-rays expose patients to additional radiation and the quality of these scans is often poor which makes it difficult to distinguish tumour from normal tissue and there may be uncertainty in the tumour position due to movement or shrinkage. To allow for these uncertainties a large margin around the tumour is also treated, but this means that large volumes of normal tissue also receive significant doses of radiation, which can result in early and late toxicity.
MRI (magnetic resonance imaging) is better than CT scanning at being able to tell the difference between tumour and normal tissues and does not expose patients to additional radiation. A new machine called an MR Linac (or magnetic resonance imaging-guided linear accelerator) integrates high quality MRI with a state-of-the-art radiotherapy machine and the Institute of Cancer Research (ICR)/The Royal Marsden Hospital (RMH) are currently installation a prototype, which will be one of the first in the world. This revolutionary technology has the potential to change the way radiotherapy is delivered. We hope the improved precision and accuracy in hitting the target will mean reductions in margins around tumours and that this will lead to higher cure rates with significantly fewer side effects. Studies are required to simulate treatment on the MR Linac before it can be used in routine clinical practice and to conduct these studies, we need to obtain MRI scans on volunteers and patients who are currently undergoing treatment. This study will involve imaging with MRI in healthy volunteers as well as in patient volunteers before and during their standard course of radiotherapy to allow us to develop MRI sequences derived on the MR Linac for MR Linac-based research focusing on clinical application and establishment into a MR-CT and MR only workflow, treatment adaptation and quality assurance.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All volunteers must undergo and satisfy MRI safety screening
Non-patient volunteers must have no known (or suspected) significant medical condition and be 18 years of age
Patient volunteers must have histologically confirmed invasive carcinoma of the tumour/target sites listed in this protocol and be under the care of a Clinical Oncologist at the Royal Marsden NHS Foundation Trust or The Christie NHS Foundation Trust and patients be planned to receive radiotherapy to target site to be imaged
All volunteers must be willing and able to provide informed consent/assent for the study
Disqualifiers
Failure to satisfy the MRI safety screening
Implanted pacemakers and/or pacing wires
Cochlear implants
Programmable hydrocephalus shunts
Trial population
There are 4 groups of participants: A) Non-patient volunteers who will take part in non-patient volunteer imaging studies of normal tissue. B) Patient volunteers who will take part in imaging studies of normal tissue. C) Patient volunteers who will take part in pathway development studies. D) non patient and patient volunteers who will take part in on going image development and continuous quality improvement of images
Trial design
Case-only
Prospective
Treatments tested in this trial
Imaging
Procedure/SurgeryThis is an observational study only, with no interventions. Volunteers will undergo MRI imaging on the MR Linac, however this will not affect, change or initiate any intervention, or change to their care path.
Treatment groups
Trial outcomes
Primary outcomes
Acceptability of the quality of imaging sequences assessed by a Visual Grading Analysis (VGA) (Stages A and B)
Inter observer registration variability (Stage C) based on the production of images of sufficient quality to allow for imaging matching and registration (assessed by validated image quality grading system)
Secondary outcomes
Intra observer registration variability (Stage C) to assess the inter observer variability in assessment of tumour position between 4 assigned observers (target: a SD of variation of less than 3mm)
Sponsors and contacts
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