A study of a new tracer that you have before a PET-CT scan to assess a neuroendocrine tumour (FETONET)

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

Cancer type:

Neuroendocrine tumour (NET)

Status:

Closed

Phase:

Phase 1

This study is looking at a new radioactive injection that you have with a PET-CT scan. The people taking part have neuroendocrine tumours (NETs).

More about this trial

Neuroendocrine tumours (NETs) develop in the nerve or gland cells that make up the neuroendocrine system. There are neuroendocrine cells in most organs of the body. The type of NET you have depends on the particular cells that are affected

A PET-CT scan can help doctors to get more information about a neuroendocrine tumour and see if it has spread elsewhere in the body.

Before you have a PET-CT scan, you have a small amount of a radioactive drug called a tracer. As cancer cells grow faster than normal cells, they will take up more of this tracer and show up on the scan.

In this study, researchers are looking at a new tracer called 18F-FET-βAG-TOCA. They think this will show up neuroendocrine tumour cells better. Taking part in the study will not change your treatment. The aims are to

Use a PET-CT scanner to see where the tracer goes in your body
Collect information about how safe this tracer is
Compare results of the scan using the new tracer with results of a PET-CT scan you had as part of your routine care

Who can enter

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

Have a neuroendocrine tumour (NET) that has grown into surrounding tissue or spread to another part of your body (your doctor can confirm this)
Have at least 1 area of cancer that can be seen on a scan and measures at least 10 mm
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
Are at least 18 years old

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

Have had chemotherapy in the last 3 weeks or radiotherapy in the last 4 weeks
Have another serious medical condition or mental health problem that the study team think could affect your taking part
Are pregnant or breastfeeding
Wouldn’t be able to tolerate having an extra PET-CT scan

Trial design

The researchers want 56 people to join this study in 2 groups. They will recruit 12 people into group 1. When they have looked at the results from people in this group, they will recruit people into group 2. Everybody taking part has an extra PET-CT scan.

If you are in group 1, the study team will put a small tube called a cannula into a vein in each of your arms before you have the scan. They use one cannula to inject the tracer. They use the other one to take blood samples before, during and after the scan. Having the scan takes 3 to 4 hours all together, but you will be able to take a break. The study team will monitor you in hospital for 24 hours afterwards. Please note the study team have finished recruiting for group 1. People will now be in group 2.

If you are in group 2, the study team will put a cannula into a vein in one arm. They use this to take a blood sample and then inject the tracer. The scan takes up to 70 minutes and you can go home afterwards.

Hospital visits

Everybody taking part has a PET-CT scan at Hammersmith Hospital in London. The study team can arrange transport for you if needed.

People in group 1 need to stay in hospital overnight after having the scan
People in group 2 can go home straight after having the scan

Side effects

The new tracer should be safe at the doses used in this study. But as it is a new tracer, there may be side effects we don’t know about yet. The study team will monitor you closely during the trial.

The total amount of radiation you have in this study is about the same as 7 years of natural background radioactivity in the UK. This is similar to a routine PET-CT scan and should not be harmful to you.