A study looking at a radioactive tracer that may help show up cancer cell death on a PET scan after chemotherapy for breast cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is looking at levels of a radioactive injection before and during a course of chemotherapy for breast cancer. They want to see if it helps doctors spot cancer cell death on a PET scan.
More about this trial
Normal cells in the body automatically die after they have reproduced about 60 times. Doctors call this apoptosis. Apoptosis helps make sure that the body gets rid of unwanted cells. Chemotherapy can also cause apoptosis. But we know that cancer cells can sometimes repair themselves and carry on reproducing, so that the tumour continues to grow.
Doctors would find it useful to know as early as possible whether or not the cancer treatment they prescribe is causing cancer cell death, so they can give you another treatment if it isn’t working.
Researchers in this study are looking at a radioactive tracer called [18F] ICMT11. This helps to show up cell death on a PET scan. Having an injection of this tracer before a PET scan may help doctors see changes in the cell within a few hours of treatment, rather than changes to the size of the cancer weeks and months later. But they need to test this.
They will recruit women due to start a course of FEC chemotherapy for breast cancer. Those taking part will have a scan before starting treatment and again within a couple of days. The aim of this study is to look at how the level of the tracer changes in tumours after chemotherapy for breast cancer.
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.
Who can enter
You may be able to enter this study if you are a woman and you
- Have breast cancer
- Have an area of breast cancer or a
lymph node 
containing breast cancer cells that measures at least 2 cm across - Are due to have a type of chemotherapy called FEC
- Have satisfactory blood test results
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are at least 18 years old
You cannot enter this study if
- You have had any chemotherapy, immunotherapy, biological therapy or trial treatment in the last 14 days, or longer if doctors think the drug will still be in your system – you can ask them about this
- You work in a job where you may be exposed to radiation and wear a badge that shows how much you are being exposed to
- You have any heart problems
- You are taking medication to thin your blood or your blood clots more slowly than it should
- A simple test shows that the team could not take blood from an
artery in your wrist - You are pregnant or breastfeeding
Trial design
This study will recruit 25 women. Everyone will have a PET scan before they start chemotherapy, and again within 14 days of starting chemotherapy.
When you come for the scan, the team will put a thin needle into an artery in your wrist so that they can take blood samples during the scan. You have a small amount of to numb your wrist first. They will then put a second small needle into a vein in your arm.
You then lie on the scanner bed. The team will inject the radioactive tracer into the vein in your arm. Before the PET scan you have a quick CT scan. This takes about a minute. You then have the study PET scan.
During the PET scan, the team will take samples of blood (about 7 tablespoons on each scan day) at regular points. The scan will last just over an hour. You need to lie very still during this time, as movement will make the scan pictures less clear. You will be able to listen to music during the scan, and bring your own CDs if you wish.
Later on the day of your second scan, or on the following day, you have a breast biopsy for the study. This will be done in the same way as when you were diagnosed.
You must not drink alcohol from 48 hours before you go to hospital for the study, until the team have phoned you the day after your study biopsy.
During this study you must not take any medicines other than those you have already been prescribed. This is for your safety and to make sure that nothing affects the results. If you need to take anything else, you must tell your doctor that you are on this study, and let the study team know as soon as possible.
The team will continue to check your records after the study to see how you are getting on.
Hospital visits
Before you join the study, you will see the doctor and have some tests. These tests include
- Physical examination
- Blood tests
Heart trace (ECG)
The team will also ask permission to study a small sample of the cancer (a biopsy) that you had removed when you were diagnosed.
They will arrange for a taxi to take you to and from each scan at Hammersmith Hospital, and your study biopsy at Charing Cross Hospital.
You need to make sure the team can contact you during the 2 weeks after the study if they need to. You may need to come to the hospital for more blood tests during this time. The team would arrange for a taxi for you if you needed to do this.
Side effects
You should not have any problems during the scan. You may feel dizzy afterwards because you will have been lying flat and have given blood samples, but this shouldn’t last long.
It may hurt having the needle put into an artery in your wrist. You may have mild bruising round where the needle went in, but this should get better within 2 weeks. If you have a lot of bruising the team may decide not to scan you a second time.
There is a small risk of damaging the blood supply to your hand, but staff have done this test many times without problems.
You will be exposed to a little extra radiation by having the study scans. We are all exposed to a very small amount of background radiation during the course of a normal day. The amount of radiation from the extra scans is about the same as 10 years of background radiation. The team believe this will not be harmful.
It is possible that the scans may pick up any tiny areas of cancer spread that you have not noticed because they are so small. If this happens, the study team will make sure that these are treated, and that you have someone to talk to about this if you would like to.
It is also possible that there may be some side effects from the radioactive tracer that the team don’t know about yet.
Side effects of breast biopsies include
- Bleeding
- Bruising
- Infection (this is rare)
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Laura Kenny
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Imperial College Healthcare NHS Trust
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
