NCT02973828Recruiting
PRIMER: Development of Daily Online Magnetic Resonance Imaging for Magnetic Resonance Image Guided Radiotherapy
Development of Daily Online Magnetic Resonance Imaging for Magnetic Resonance Image Guided Radiotherapy (MRIgRT)
Source: ClinicalTrials.gov · Last updated 6 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 173 (estimated)
- First submitted
- 9 Nov 2016
- Start date
- 17 Oct 2017
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Diseases
- Childhood cancers
- NCT number
- NCT02973828
What you commit to
- Study type: Observational
- Planned participants: 173
- From 17 Oct 2017 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cochlear implants
- Implanted drug infusion pumps
Other illness
- Any conditions that would be a contra-indication to MRI including:
- Failure to satisfy the MRI safety screening
- Ferromagnetic implants And additional conditions that may place volunteers at increased risk from MRI procedures including:
- Known susceptibility to seizures or migraines
Other
- Implanted pacemakers and/or pacing wires
- Programmable hydrocephalus shunts
- Implanted neurostimulation systems
- Fever, reduced thermal regulatory capabilities or increased sensitivity to raised body temperature (for example pregnant women)
Who the study is looking for
- 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
Age in the registry: 3 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.