"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at PET-CT targeted biopsy to diagnose cancer of the covering of the lungs (TARGET)
This trial is for people who are due to have a biopsy as they might have cancer in the tissues covering the lungs (the pleura).
Cancers that can affect the pleura of the lungs include:
- pleural mesothelioma
- lung cancer
- other types of cancers that have spread to the covering of the lung
People must have already had one biopsy which did not show cancer.
More about this trial
A chest X-ray can sometimes show that the pleura has become thicker. This thickening is a possible sign of cancer. The doctor usually takes a sample (
Sometimes the biopsy does not show cancer cells (negative result) or the result is not clear. But there might be others reasons why the doctor thinks their patient has cancer (malignancy) of the pleura.
A PET-CT scan highlights area where cells are more active. Cancer cells are usually more active than normal cells. So doctors think that a PET-CT scan might be better at showing them the best place to take a biopsy.
In this trial half of the people have a standard CT guided biopsy of the pleura. The other half have a PET-CT scan, followed by a CT guided biopsy.
The aim of this trial is to find out whether a PET-CT scan, followed by a CT guided biopsy is better at diagnosing cancer of the pleura.
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply.
- You have had a CT scan that shows thickening of the pleura and your doctor thinks you might have pleural cancer (malignancy)
- You have had a biopsy sample of your pleura in the last 6 months which has not shown cancer (a negative result)
- Your multidisciplinary team (MDT) have decided that you should have a further CT guided biopsy
You cannot join this trial if any of these apply. You
- Are unable to have a CT guided biopsy for any reason. This might be because you are unable to lie down during the scan or because there is a medical reason why you can’t have this biopsy. For example, there is a problems with your blood clotting
- Are pregnant or breastfeeding
- Have had treatment for fluid on the lung called a talc pleurodesis
- Are under the age 18
- Are unable to read the information about the trial and sign the consent form
The researchers need 78 people to join.
It is a randomised trial. The people taking part are put into 1 of 2 groups by a computer. Neither you nor your doctor will be able to choose which group you are in. But you will know which group you are in.
- One group has a CT guided biopsy
- The other group has a PET-CT scan followed by a CT guided biopsy
CT guided biopsy group
You have your CT guided biopsy within 2 weeks of joining the trial.
There are different ways of having a CT guided biopsy. Your doctor will explain what is going to happen in your situation. You have a local anaesthetic to make the area numb and you have a medicine to make you drowsy (sedation).
PET-CT and CT guided biopsy group
You have a PET-CT scan within about a week of joining the trial.
You are asked not to eat or drink 6 hours before your PET-CT scan. Do not have caffeinated drinks such as tea, coffee and cola in the 24 hours before the scan. This can affect the scan, giving the wrong results. You have specific instructions about not eating and drinking if you are diabetic.
Before your PET-CT scan you have a small tube (a cannula) put into your arm or hand. This is for an injection of radioactive dye. You wait about 1 ½ hours for the dye to be taken up by abnormal cells, such as cancer cells. Then you have the scan.
You lie still during the scan. You can talk to the radiographer through an intercom if you need to. It takes about 30 minutes.
You have your CT guided biopsy a few days later. Having the PET-CT scan should not delay your biopsy.
People in both groups have a guided CT-scan within about 2 weeks of their first appointment with the trial team.
If you are diagnosed with cancer, your doctor will talk through what support and treatment is available.
Before you take part in this trial, you go to hospital to see a doctor or nurse in the trial team. They ask you various questions about your health and you have some blood tests.
You have an extra hospital visit if you have a PET-CT scan.
About 2 weeks after your CT-guided biopsy you have an appointment with the trial team. This might be at hospital, or it might take place over the telephone. You will get your results and discuss treatment options if necessary.
You have further appointments 3, 6 and 12 months later. Your 3 month appointment can take place over the telephone. The trial team ask how you are and about any treatment or further tests and results you have had.
The PET-CT scan uses a radioactive dye that you would not be exposed to as part of your routine care. It is a mildly radioactive dye and the dose is low.
Everyone is exposed to radiation from natural sources in our everyday life. For example, rays from the sun or radioactive substances in the soil. A PET-CT scan is the same as 7 times the natural background radiation we are exposed to in 1 year.
The dye leaves the body naturally and will be completely gone a few hours after your scan. But as a precaution, avoid close contact with children or pregnant women for up to 12 hours following the scan.
How to join a clinical trial
Professor Nick Maskell
NIHR Research for Patient Benefit (RfPB) Programme
North Bristol NHS Trust