“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."
A study looking at a new type of PET-CT scan for women with breast cancer (FRONTIER)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study wants to find out whether a type of PET-CT scan called fluciclovine PET-CT scan can show up breast cancer.
It is for women who are going to have treatment for the first time at the Churchill hospital in Oxford.
More about this trial
A PET-CT scan combines a CT scan and a PET scan to give detailed information about the cancer. It can help doctors decide the best treatment for you and show how well a cancer treatment is working.
In this study, doctors are using a new type of PET-CT scan called fluciclovine PET-CT scan (18F PET-CT scan). Fluciclovine is a mild
Doctors think that the 18F PET-CT scan can show up breast cancer and show how the cancer grows and develops.
Everyone taking part has a 18F PET-CT scan before they start treatment.
The main aim of this study if to find out how well breast cancer cells take up the fluciclovine dye (tracer).
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.
Who can take part
You may be able to join this study if you are a woman and all of the following apply. You:
- have invasive breast cancer or ductal carcinoma in situ (DCIS) that measures at least 1.5 cm across
- are going to have treatment for breast cancer for the 1st time
- are aged 40 or older
- are willing to use reliable contraception during treatment if there is any possibility that you could become pregnant
Who can’t take part
You cannot join this study if any of these apply. You:
- have more than 2 breast cancer tumours (multifocal breast cancer)
- have had an experimental treatment or have taken part in another clinical trial in the past month
- have another cancer or you have had melanoma skin cancer
- have had a major operation or trauma (injury) in the past month
- are sensitive to fluciclovine or anything it contains
- have any other medical condition or mental health problem that the trial team think could affect you taking part
- are pregnant or breastfeeding
Researchers hope that about 45 women who are having treatment at the Churchill hospital in Oxford will take part.
Everyone has a 18F PET-CT scan before the start of treatment. You have the scan in the following way:
- you have an injection of fluciclovine dye into a vein through a small plastic tube (a cannula)
- you then lie still on a couch for about 25 minutes (this gives time for the dye to be taken up by the cancer cells)
- then you have the scan
It takes about 1 and a half hours in total to have the 18F PET-CT scan. You cannot eat for 4 hours before the test, but you can drink water.
You start treatment at least at day after the PET-CT scan. This is the same as if you weren’t taking part in this study. Treatment might be:
- surgery to remove the cancer
- other treatments such as chemotherapy, radiotherapy, hormone therapy or targeted drugs
Your doctor will tell you more about the treatment you are having and what to expect.
Blood test and tissue sample
You have an extra blood test as part of this study. Researchers will take the blood test from the same small plastic tube (cannula) that you have during the PET-CT scan.
The research team might also ask for a tissue sample of your cancer. Doctors will either:
- take a tissue sample at the time you have surgery as part of your normal treatment
- ask you to have a needle biopsy (this is the same test you had to diagnose the cancer)
You have the PET-CT scan at the Churchill hospital in Oxford. You may be able to have the scan at the same time you are already at the hospital for routine tests and treatments.
The trial team will call you a month after the scan to see how you are.
You see the doctor regularly after treatment. This is part of your normal follow up.
PET-CT scans are very safe and the team doesn’t think you will have any side effects from it.
During the scan, you have a mild radioactive dye. We are all exposed to small amounts of radiation during the course of a normal day (background radiation). The amount of radiation you have from this scan is the same as about 4 years of background radiation in the UK.
You may have some side effects from the fluciclovine dye. They might include:
- redness and pain at the injection site
- taste and smell changes
- an allergic reaction
We have more information about having a PET-CT scan.
How to join a clinical trial
Professor Adrian Harris
Cancer Research UK
Blue Earth Diagnostics Ltd
Engineering and Physical Sciences Research Council (EPSRC)
Medical Research Council (MRC)
Oncology Clinical Trials Office (OCTO)
Oxford Clinical Trials Research Unit (OCTRU)
University of Oxford