Functional MRI in rectal cancer study
SE LONDON CANCER RESEARCH NETWORK
Cancer Network Research Manager: Kerrie Montoute
Chief Investigator: Dr Andrew Gaya
Tel: 0207 188 4216
Fax: 0207 188 7076
helen.l.tapp@gstt.nhs.uk
allan.paras@gstt.nhs.uk
roni.cummings@gstt.nhs.uk
andrew.gaya@gstt.nhs.uk
Study Title: Functional Magnetic Resonance Imaging In Colorectal Cancer
Ethics Committee Reference Number: 08/H0804/6
PATIENT INFORMATION SHEET (Version 2) 14th May 2008
You have been invited to take part in a research study. Before you decide it is important that you understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with friends, relatives and your GP if you wish. Ask us if there is anything that is not clear or if you would like more information.
What is the purpose of the study?
This research is designed to find out more about what happens to colorectal tumours during treatment. One of the main barriers to effective cancer treatment is lack of oxygen and blood supply to the tumour. Cancers require a blood supply to deliver oxygen and nutrients to the cancer cells. In order for cancers to grow they have to make their own blood supply. Some cancer cells have a very good blood supply whilst others have a poor blood supply. The cancer cells with a poor blood supply are known to be much more resistant to conventional treatments like chemotherapy (drug treatment) and radiotherapy (x-ray treatment) because there is less oxygen around. This is called tumour hypoxia.
In order to improve the effectiveness of treatment we need to either improve the blood supply to the tumour so that chemotherapy and radiotherapy work better, or cut off the blood supply completely so the cancer cells die. Research teams all across the world are looking at ways to make this happen.
Currently the scans that you have before and after treatment only look at the size of the tumour to see whether it has responded to treatment. It is now widely accepted that size is not always the best way to examine whether a cancer has responded to treatment. Many new therapies don’t actually kill cancer cells, but do stop them from growing further, so the size of the cancer may not change very much. How do we know if these treatments are effective?
New types of scans are becoming available which can look at what is going on ‘inside’ cancers as well as the size of the tumour. This is known as ‘functional imaging’. With magnetic resonance imaging (MRI) we can now look at blood flow within the tumour and determine whether the tumour is well oxygenated or not.
We hope that this research will help direct future studies in colorectal cancer by determining whether these tumours suffer from a poor blood supply.
What will happen to me during the study?
If you were not taking part in this study you would have two standard MRI scans – One before and one after treatment to look at the size of the tumour(s).
This study will involve you having up to two extra MRI scans which can be carried out before, during or after treatment (i.e. a maximum of 4 MRI scans in total). This is so that we can be sure that our research scanning technique is reproducible from day to day; we will then be more certain that any results we find are not simply due to chance. You do not have to have all the scans but we would appreciate it if you could – The more scans you have, we obtain more useful information.
The MRI scans will also take about 20 – 30 minutes longer than a standard MRI scan. This is because we have to get the extra information about the tumour blood supply in addition to the standard information. MRI uses a magnetic field and radio waves to produce cross-sectional images of the body. It is completely painless. A cannula (plastic needle) is placed in a vein in the arm so that some contrast dye can be given during the scan. The contrast helps to show up the blood vessels. You will be asked to lie on a couch in the magnet tube and will hear a loud rhythmic knocking noise whilst the scan takes place. You may feel a little claustrophobic but you can listen to music via headphones to help you relax. You can also talk to staff via an intercom whilst in the scanner. Depending on the position of the tumour, you may be asked to hold your breath for short periods during the scan. The scan lasts 50 - 60 minutes.
What do I have to do?
You will have to attend Guy’s or St Thomas’ hospitals for your MRI scans. That is all.
Are there any side effects associated with these treatments?
MRI is completely painless and very safe. There is no ionizing radiation involved. The scanner is a big magnet and we use radio waves to create the images. If you have any metal implants such as a hip or knee replacement, cardiac stents, brain aneurysm clips, you must let us know, but most of the time these are ok. Some people feel a bit claustrophobic in the scanner but we will be talking to you via intercom and can play relaxing music through the headphones. There are no known side effects to MRI scanning.
Occasionally (about 1% of the time) patients experience a mild adverse reaction to the contrast injection. If this happens staff are always nearby to treat the reaction straight away. More serious adverse reactions are extremely rare (about 1 in every 100,000). Sometimes the contrast injection can also cause a ‘hot’ feeling or ‘itchy’ feeling which is usually mild and quickly passes.
What are the possible benefits of taking part?
You will not benefit directly from this research but we hope it will provide valuable information which could lead to more effective treatments in the future.
What if something goes wrong?
The chance of anything going wrong during the MRI scans is very small. If you were harmed by taking part in this study, no special compensation arrangements exist. If you were harmed due to someone’s negligence, then you would have grounds for legal action. Regardless of this, if you have any cause to complain about any aspect of the way you have been approached or treated during the course of this study, you can follow the Guy’s & St Thomas’ NHS Trust complaints process.
Will my information in this study be kept confidential?
All information which is collected about you during the course of this study will be kept strictly confidential. Any information about you which leaves the hospital will have your name and address removed, so you cannot be identified from it.
Who is organising and supporting the research?
This study is organised by Dr Andrew Gaya, Dr David Landau and Dr Geoff Charles-Edwards. The study sponsor, as defined by the EU Clinical Trials Directive, is Guy’s & St Thomas’ NHS Trust. The study has been approved by the Guy’s & St Thomas’ NHS Foundation Trust Ethics committee.
What if I do not wish to take part or change my mind?
The study is voluntary so that you should not feel under any pressure to enter. If you decide to take part you are free to withdraw at any time. In either case you do not have to give a reason for your decision and this will have no influence over your future medical care. If you decide not to participate in the study, then your doctor will discuss other options with you. If you do decide to take part in this research study, you will be asked to sign a consent form.
Should you have any further queries regarding this study or about any of the treatment described above, you should contact:
Study contact details:
Your Consultant Oncologist or surgeon or a member of their team
Guy’s & St Thomas’ Colorectal Research Nurses 0207 188 4216
Out of Hours number 0207 188 7188 , bleep 0600