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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3+
SponsorInstitute of Cancer Research, United Kingdom

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Imaging

    Procedure/Surgery

    This 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

173 Participants
are divided into 4 treatment groups
Group A: A) Volunteer Imaging Studies1 intervention
Group B: B) Patient Volunteer Imaging Studies1 intervention
Group C: C) Pathway development studies1 intervention
Group D: D) On going imaging development & quality improvement1 intervention

Trial outcomes

Primary outcomes

1

Acceptability of the quality of imaging sequences assessed by a Visual Grading Analysis (VGA) (Stages A and B)

Time frame
12 months to build exam cards. Information gained after each cohort is recruited will build up in the definition of protocol imaging
2

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)

Time frame
Assessment will be done for each imaging sequence available for each patient at each time point for imaging aquired up to one year.

Secondary outcomes

1

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)

Time frame
Assessment will be done for each imaging sequence available for each patient at a specific time point. Up to 2 year recruitment period.

Other outcomes

Sponsors and contacts

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