NCT02973828 PRIMER: Development of Daily Online Magnetic Resonance Imaging for Magnetic Resonance Image Guided Radiotherapy

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 173 participants in total. It began in 2017-10-17 with a primary completion date of 2026-12-31.

Brief Summary

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

Inclusion Criteria: * 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 * Paediatric patient volunteers between the ages of 3 and 18 years, will have consent provided by his or her legal guardian who is 18 years of age * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Exclusion Criteria: Any conditions that would be a contra-indication to MRI including: * Failure to satisfy the MRI safety screening * Implanted pacemakers and/or pacing wires * Cochlear implants * Programmable hydrocephalus shunts * Implanted neurostimulation systems * Implanted drug infusion pumps * Ferromagnetic implants And additional conditions that may place volunteers at increased risk from MRI procedures including: * Known susceptibility to seizures or migraines * Fever, reduced thermal regulatory capabilities or increased sensitivity to raised body temperature (for example pregnant women)

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