A study looking at a new type of MRI scan to help plan and see how well radiotherapy works for non small cell lung cancer

Please note this trial is no longer recruiting patients.

This study is to see if using a scan called ‘Helium 3 MRI’ can help doctors to see how well the lung tissue not affected by cancer is working.

When doctors plan radiotherapy for lung cancer, they try to treat as little healthy lung tissue as possible. This can be difficult as scans do not show up healthy lung tissue very clearly. The larger the radiation dose to the lung, the greater the risk of a side effect called radiation pneumonitis. If doctors could see healthy lung more clearly, they could reduce radiation to these areas. And possibly reduce the risk of radiation pneumonitis.

Researchers are looking at a new type of scan called ‘Helium 3 MRI’ to show healthy lung tissue. This is similar to a regular MRI scan, but works in a slightly different way. Regular MRI scans are good at showing up body tissue. But lungs do not show up very well because they are full of air. Helium 3 MRI involves breathing in a gas called Helium 3. The areas of lung that the helium can reach will then show up on the scan. Doctors should be able to see which parts of the lung are still working, so they know where to try and reduce radiation doses when they plan treatment. Researchers will also compare information from these scans with normal MRI scans, CT scans and breathing tests. The main aims of this study are to see if Helium 3 MRI scans can

Help reduce radiation to healthy lung tissue, reducing radiation pneumonitis
Show doctors how well lungs are working after treatment

You will not have any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the results of the study will be used to help people with cancer in the future.

Recruitment

Start 20/04/2006

End 11/03/2011

Phase

Phase 1/2

Who can enter

You can enter this study if you

Have non small cell lung cancer
Are due to have radiotherapy to try to cure your cancer (radical radiotherapy) or a high dose to treat symptoms (palliative radiotherapy) - you can check this with your doctor
Are due to have a CT scan as part of your radiotherapy planning appointment
Are able to have MRI scans (for example you do not have any metal or a pacemaker in your body, and you are not worried by being in small spaces)
Are at least 18 years old

You cannot enter this study if you

Have any conditions that would stop you having radiotherapy
Have kidney problems – you may react to the MRI contrast dye gadolinium
Are not able to understand English well enough to read the information or talk to the research team without an interpreter
Are pregnant or breastfeeding

Trial design

This study will recruit 20 people. Everyone will have the treatment their doctors have already planned for them. You will also have

2 extra CT scans during your radiotherapy planning session
2 breathing tests (lung function tests)
3 MRI scans

You fill out a questionnaire before you start treatment and about 2 months after your treatment. The questionnaire will ask you about any side effects you have had and about how you have been feeling. This is called a quality of life study.

You should be able to have these scans and tests on the same day as your clinic appointments. You will need to visit 2 hospitals in Sheffield. The hospitals are next door to one another, and a member of staff will stay with you for most of the day to help you find your way around.

You will have your radiotherapy planning session in the morning at Weston Park Hospital. Doctors plan your radiotherapy using CT scans. For the study, you will have 2 extra CT scans, which will add 5 minutes to the session. The radiographer will ask you to hold your breath for a few seconds for these. You will be able to practice this before your study scans.

You then go next door to the Royal Hallamshire Hospital to have a breathing test. This test will take up to 30 minutes. Later the same day you have your study MRI scans at the same hospital.

Before your MRI scans you fill out a safety form, and remove any metal jewellery or clothing. You will have 2 different MRI scans at each visit. For one scan you will breathe in helium gas. For the other scan you have an injection into a vein. The helium gas and the injection work in different ways to make the scans clearer. Each scan will take about half an hour.

You will have another MRI scan 3 weeks after you start radiotherapy. When you finish treatment, you will have another MRI scan and breathing test.

Throughout the study, you will continue to see your regular cancer specialist.

Hospital visits

Where possible, you will have the study scans and breathing tests on the same day as your routine clinic appointments. So although you may need to visit a different department or site, and your appointments overall will take longer, you should not have to spare extra days to take part in this study.

Side effects

Side effects of ‘helium 3 and nitrogen’ MRI study gas include

Increase in heart rate
Decrease in oxygen levels in your blood
Chest tightness
Tickly throat

These are likely to be mild and only last a very short time.

Side effects of the MRI contrast dye gadolinium can include

Mild headache
Feeling sick
Low blood pressure
Light headedness

Very rarely the contrast dye may cause an allergic reaction. Staff at the MRI unit will be able to treat this if it happens.

Anyone who has a CT scan is exposed to a small amount of radiation. Doctors think that you are very unlikely to notice any health problems from having 2 study CT scans.