A study looking at using a radioactive tracer to help learn more about a substance found in cells called integrin alpha v beta six (IMPACT)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

All cancer types

Breast cancer

Head and neck cancers

Pancreatic cancer

Status:

Closed

Phase:

Pilot

Integrin alpha v beta six (αvβ6) is a substance found in high levels in some cancer cells. It plays a role in the development of cancer and its ability to spread.

In this study doctors want to use a radioactive tracer called [18F]FBA-A20FMDV2. It is given as part of a PET scan to try to measure the amount of integrin αvβ6 in cells. It is for people with a solid tumour Open a glossary item .

More about this trial

FBA-A20FMDV2 sticks to integrin αvβ6. By attaching a small amount of radioactivity to FBA-A20FMDV2 and using a PET scan the doctors hope to be able to find and measure the amount of integrin αvβ6 in the cancer (tumour).

Doctors think if they can measure the amount of αvβ6 in cancer cells it will help them to understand more about the cancer and, in the future, help develop treatment to target αvβ6. But first they need to find out if doing a PET scan using [18F]FBA-A20FMDV2 works for people with a solid tumour.

You will probably not have any direct benefit from taking part in this study. The doctors hope information from this study will help people with the same type of cancer as you in the future.

Who can enter

The following bullet points list 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.

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

Have been diagnosed with a solid tumour and have an area at least 1cm that can be seen on a scan or measured by your doctor
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have satisfactory blood test results
Have a sample of your cancer available for testing (your doctors will check for this). If there is a not a suitable sample available you might be asked to have another one taken (a biopsy )
Are willing to use reliable contraception from the day of the scan and for 4 weeks afterwards if there is any chance that you or your partner could become pregnant
Are aged 18 years or older

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

Have been exposed to animals that might have foot and mouth disease (FMDV2)
Have lived in any country (for 3 months or longer) where foot and mouth disease is very common (endemic)
Are not able to lie flat and still for the time of the scan (up to 95 minutes)
Have any medical condition or mental health problem that the study team think could affect you taking part
Are pregnant or breastfeeding

Trial design

This is a pilot study. The doctors need 12 people to take part.

You’ll be asked if you would like to take part if your doctors think you have a type of cancer that has a high level of integrin αvβ6. The types of cancers this includes are:

Everyone taking part has one PET scan. These take place at the Imanova Imaging Centre in London.

Before your PET scan you have a small plastic tube (a cannula) put into your arm. The radioactive tracer is injected into the cannula before the scan.

The scan takes up to 95 minutes and you need to lie flat and still. If you want, you can listen to music. You might not have the scan straight after having the injection and so should allow up to half a day at Imanova.

Blood samples
As part of the study the doctors need some extra blood samples for research. These are taken at the same time as the routine blood tests done to check your general health. You have these samples taken about a month before your scan and then about 2 to 3 weeks after your scan.

Tissue sample
Because the doctors need to know if your cancer has high levels of integrin αvβ6 they will ask your permission to look at a sample of your cancer that has been taken in the past. If there is not a suitable sample available you might be asked to have a biopsy.

If you don’t want to have a biopsy or it can’t be done before you enter the study, you may still be able to take part. Your doctor will discuss this with you.

Hospital visits

Around a month before your PET scan you have:

blood tests
a physical examination
height and weight recorded

You are also asked about your past medical history and any illnesses or symptoms you currently have. This is done at the hospital where you have your usual care.

You have your PET scan at the Imanova Imaging Centre in London. You need to allow about half a day for your visit.

Within 3 days of your scan someone from the study team will phone you to see how you are and about ask any illnesses or symptoms you have.

Then 2 to 3 weeks after the scan you go to the hospital where you’re having your usual care to have some blood tests and be asked again about any illnesses or symptoms you have.

Side effects

[18F]FBA-A20FMDV2 has been used on healthy volunteers and people with a lung condition called idiopathic pulmonary fibrosis (IPF). There have been no known side effects from this radioactive tracer in anyone who has had it.

FBA-A20FMDV2 is created using the virus that causes foot and mouth disease. So there is a small risk of an allergic reaction if you have been exposed to animals with foot and mouth or have lived in countries where this is very common. The study is not including people in these situations to help reduce the risk of this happening.