Series No. 65 - A service evaluation of MRI scanning as part of the pre-treatment process in proton beam therapy

It is up to you to decide whether to take part or not. If you do decide to take part, you will be given this information sheet and be asked to sign a consent form. You are free to withdraw at any time and without giving a reason. If you decide not to take part, it will not affect your treatment or the standard of care you receive in any way.

We would like to invite you to have a pre-treatment MRI planning scan in addition to your current pre-treatment CT planning scan.

MRI is a cross sectional imaging technique that uses a strong magnetic field to image people. It can produce high-definition images which are great for looking “inside” the body. MRI is a safe and well-established imaging technique in the pre-treatment planning pathway of patients having radiotherapy, and proton beam therapy.

The Proton Beam Therapy Department at UCH has a new dedicated MRI scanner which will be used as part of the pre-treatment process for patients having proton beam therapy and photon radiotherapy.

We want to increase our range of scanning techniques and to evaluate MRI image quality to assist the clinical teams in planning patients’ treatment. Our evaluation will involve implementing MRI techniques and ensuring the quality of images before MRI becomes part of our routine practice.

You have been asked as we would like to MRI a variety of radiotherapy treatment sites in the radiotherapy position. Your radiotherapy doctor felt you may be a suitable volunteer.

If you decide to take part, you will have a radiotherapy CT planning scan in the radiotherapy department. Afterwards you will be taken to the proton beam therapy department where you will have an MRI planning scan.

The MRI radiographer will go through a safety checklist and consent form with you. You will be asked to change into a hospital gown (as some clothes contain metal which would affect the MRI scan). You will need to remove all items of jewellery and any body piercings. You will be positioned on the MRI scanner couch in the same position as for your CT planning scan. We may attach a few small, self-adhesive markers to your skin, which we would be able to see on the images. These are temporary and can be removed immediately after the scan. The MRI scan may last for up to an hour, sometimes a little longer, but no more than 90 minutes.

During this time, you will be asked to remain quite still. However, in some cases you may be asked to move in a specified way for part of the time, as our research includes studying and correcting for the effects of motion on MRI images. Sometimes you may be asked to hold your breath for one or more short periods during scanning. The exact details of the procedure in your specific case will be explained to you before we begin.

While the scanner is acquiring images it is very noisy. You will be given earplugs and headphones to wear, to protect your ears from the noise. The headphones will also allow you to hear what the radiographer says. There is also a microphone attached so that you can talk to the radiographer when we are not scanning. You will also be given a patient alarm buzzer to hold, which you can squeeze to get immediate attention. You can stop the scan at any time by pressing the patient alarm buzzer.

The PBT MRI system has an ambient experience system which helps relax you during your scan. There are screens on two walls of the room which can show nature related imagery. Patients can choose different settings such as underwater or in the mountains. The lights in the scan room also change colour to match the journey. We may use this system during your scan if you are happy with this. It can be stopped at any time if you are not enjoying it.

MRI has been used to image millions of patients worldwide. Although the possibility of long-term effects cannot be completely ruled out, the weight of experience and opinion is against this.

Some people find being inside an MRI scanner a slightly claustrophobic experience, although this is less so with the latest, wide bore systems like those at UCH. If you do find the experience unpleasant, we will stop and bring you out of the scanner. Because MRI involves a very strong magnet, some people are excluded. These include people with pacemakers and other implanted devices, those with metal foreign bodies for e.g., shrapnel from accidents and those who have had certain types of surgery.

Although MRI is not known to affect the unborn child, we exclude subjects who may be pregnant.

Currently, this evaluation is restricted to completely non-invasive procedures, which means there are no injections for the MRI scan.

These scans may help you and others in the future. The MRI images will be used by your clinical team to assist them in planning your treatment. Taking part in this study will not affect any treatment you are receiving at this or any other hospital.

All personal information which is collected about you during the course of the evaluation will be kept strictly confidential and will be kept within UCH. The images will be stored, handled and processed at UCH via PACS and EHRS – the hospital electronic imaging and health records systems.

The investigators are responsible for the safety and security of the data.

You are not affected by the end of the evaluation. We are increasing our working knowledge of the MRI scanner and its image quality. We do not give any treatment.

Complaints:

If you have any concerns or wish to complain about any aspect of the way you have been approached or treated as part of this evaluation, you should contact the UCH Proton Beam Therapy department who will do their best to answer your questions.

If you remain unhappy, you can contact the UCLH Patient Advice and Liaison Service (PALS) in person between 9.00am and 16.00pm Monday to Friday (excluding public holidays) at:

PALS Office,
Ground Floor Atrium
University College Hospital,
235 Euston Road,
London NW1 2BU

You can also contact PALS by telephone. From within the hospital dial extension 73018, 73002 or 73042 or from outside the hospital ring the direct line 020 7380 9975 or e-mail to PALS@uclh.nhs.uk.

If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. Details can be obtained from UCLH or PALS.

The scan is considered to be low risk as it involves the completion of screening questionnaires to highlight any issues related to being scanned in a strong magnetic field. However, every care will be taken to ensure your safety, UCLH has indemnity (insurance) arrangements in place for non-negligent harm, in the event that something does go wrong, and you are harmed as a result of taking part in the evaluation. If you are harmed due to someone’s negligence, then you may have grounds for legal action, but you may have to pay for it.

The normal NHS complaints mechanisms should be available to you.

The results will provide evidence to make necessary changes and alterations to our MRI planning protocols. It will also improve the image quality of MRI scans and allow the full integration of MRI scanning into the Proton Beam Therapy pathway.

No funding is necessary for this evaluation as it is clinically led.

If you have any questions or queries, please contact:

Anna Crawley or Turmi Patel
020 3447 3756
UCH Radiotherapy
235 Euston Road
London NW1 2BU