A study looking at measuring oxygen levels in cervical cancer (Bio-CHECC)

Cancer type:

Cervical cancer

Status:

Open

Phase:

Phase 2

This study is looking at 2 ways to measure low levels of oxygen in cervical cancer.

It is for people having radiotherapy to treat cervical cancer.

It is open only to people having treatment at the Christie Hospital NHS Trust in Manchester.

More about this trial

All living cells need a blood supply. This supplies oxygen and nutrients for growth. In cancer, abnormal cells grow in an uncontrolled way and so they may outgrow their blood supply. This means some areas within the cancer have low levels of oxygen. We know from research that cancers with low oxygen levels are more likely to spread and sometimes treatment doesn’t work as well.

Researchers want to improve treatment for people with cervical cancer. In this study, they plan to measure levels of oxygen in areas of cancer. The team are looking at 2 ways to measure low levels of oxygen:

tumour samples (biopsies )
MRI scans

The researchers plan to use the scans and tissue samples to look at substances in the body (biomarkers Open a glossary item ). They think this will help them to work out who could benefit from treatment to improve oxygen levels in the cancer. And they think this could help doctors to tailor treatment to the individual.

The main aims of the study are to see if:

it is possible to find and develop biomarkers to work out who has low levels of oxygen in their cancer
biomarkers can help predict who treatment will work best for

Please note, you won’t benefit directly from taking part in this study. It might help other people with cervical cancer in the future.

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if all of the following apply. You:

have cervical cancer that has grown into surrounding tissues. This is locally advanced cancer.
have a sample of cancer tissue (biopsy ) that the study team can access
are suitable to have external radiotherapy and internal radiotherapy (brachytherapy )
have satisfactory blood test results
are up and about for at least half the day but might not be able to work (performance status 0,1 or 2)
are willing to use reliable contraception if there is any chance you could become pregnant
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply. You:

have cancer that has spread to another part of the body
aren’t suitable to have tissue samples taken during or after radiotherapy
have a pacemaker , a device that improves hearing (cochlear implant), metal pierced your eyeball in the past or there is any other reason you can’t have an MRI
have had a hip replacement
are allergic to the contrast dye used in scans
are allergic to a medication called hyoscine butylbromide (Buscopan)
are taking a type of medication to lower you blood pressure called an ACE inhibitor. You may be able to join if your doctor thinks you can swap to a different type of medication.
have a problem with how your kidneys work
are taking part or have recently taken part in another clinical trial
are pregnant or breastfeeding
have a severe or uncontrolled medical condition or a mental health problem that could affect you taking part

Trial design

This phase 2 study is for people having treatment at the Christie Hospital NHS Trust in Manchester. The team need to find 30 people to take part.

The study team ask if you would like to take part in the study on the day you have your radiotherapy planning session. You can say no if you don’t want to join. If you agree to join, they arrange for you to have your first study scan.

You then have your radiotherapy treatment as planned. Your doctor can tell you more about this, what it involves and how often you have it.

Study scans
You have up to 7 MRI scans Open a glossary item as part of the study:

1 before you start treatment
5 during treatment. This works out to be one scan per week. The team try to arrange the scans on the same day of the week. And on the same day that you go to hospital for treatment.
1 when you finish treatment

The scans take about 60 minutes each time. You have a special preparation before each scan. This is called a contrast medium Open a glossary item . This helps to get more information about the cancer.

You wear a facemask during the scan to breathe oxygen. Some people have carbogen and nicotinamide instead of oxygen. Carbogen is a gas containing mainly oxygen and nicotinamide is a form of vitamin B3. You wear a facemask to breathe carbogen gas instead of oxygen and take a nicotinamide tablet. The team will see how carbogen and nicotinamide affect oxygen levels in the cancer.

Most people have their radiotherapy and scans separately. Some have radiotherapy on a new machine called the MR-Linac. The MR-Linac is a machine that combines an MRI scan with a linear accelerator Open a glossary item . This means you have your radiotherapy and scans all at the same time. The team will let you know if you have your radiotherapy using this machine.

Tissue sample for research
The team ask for an extra tissue sample (biopsy Open a glossary item ) after 5 weeks of radiotherapy treatment.

Other information
The study team ask your permission to access your medical records. They need to collect information about:

any other medical conditions
your diagnosis of cancer
treatment and how well it worked
test results

If your cancer comes back the team will ask you:

for a sample of your cancer following any biopsies you have
to have an extra MRI scan

You can say no to this if you don’t want to.

Hospital visits

You shouldn’t have any extra hospital visits if you join this study. The study team try to arrange all your scans on the days you have treatment or attend for another routine hospital visit.

Side effects

MRI scans are safe and the study team don’t think you will have any side effects from it.

The most common side effects of giving a tissue sample are pain and a bit of bleeding.

The most common side effect of nicotinamide tablets is feeling a bit sick. The facemask you wear during the scans can be a bit uncomfortable and you might feel a little short of breath for a few minutes when you first put it on.

We have more information about having an MRI scan.