A trial looking at a new way of testing thyroid nodules to see if they are cancerous or not (ElaTION)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at a new ultrasound method called real time ultrasound elastography, to see if it helps show whether lumps in the thyroid gland are cancerous or not.
Lumps in the are called nodules. Thyroid nodules are very common, but only about 1 in 20 thyroid nodules are thyroid cancer.
More about this trial
If you have a thyroid nodule, you may have an ultrasound scan. During the scan, the doctor can put a needle into the nodule to remove some cells. This is called a needle biopsy.
When you have a needle biopsy, the cells are looked at under a microscope to see if they are cancerous or not. But sometimes it is difficult to be sure, so you may need to have another biopsy. And for some people the only way to make sure is to have surgery to remove the nodules.
In this trial, researchers are looking at new ultrasound method called real time ultrasound elastography or RTE. Elastography looks at the firmness of the thyroid nodule. If a nodule is hard, it is more likely to be cancerous. If a lump is soft, it is more likely to be non cancerous (benign). Having elastography as well as an ultrasound guided needle biopsy may make the test more accurate.
The aim of the trial is to see if RTE and a needle biopsy is better at showing when a nodule isn’t cancerous than a standard ultrasound scan and needle biopsy. This will hopefully reduce the time it takes to reach a final diagnosis.
Who can enter
You may be able to join this trial if all of the following apply. You
- Have a lump in your thyroid gland (a thyroid nodule) that your doctor can feel when they examine you, or that has been seen when you had a scan for something else (you may have more than 1 nodule)
- Are having tests to find out whether or not the nodule is cancer
- Are at least 18 years old
You cannot join this trial if any of these apply.
- You have already had a needle biopsy of your thyroid gland in the last 6 months
- You can’t have a needle biopsy, either because you have a tendency to bleed a lot, or you have a fear of needles (needle phobia)
- All the nodules you have are filled with fluid and don’t have any solid areas (you will have an ultrasound scan to check this before you can join the trial)
- You are pregnant
Trial design
This 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 decide which group you are in.
Half the people taking part have an ultrasound scan and needle biopsy. This is the standard way of testing thyroid nodules.
The other half will have real time ultrasound elastography (RTE) and needle biopsy.
Whichever group you are in, the trial team will ask your permission to take a blood sample for research.
The trial team will ask you to fill in a questionnaire before you have your ultrasound then after your 1st ultrasound at
- 3 months
- 6 months
- a year
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You have the ultrasound scan and needle biopsy as an outpatient. It takes between 5 and 10 minutes.
The trial team will ask to see some people again 3 months and a year later.
Side effects
You may feel a sting when the biopsy needle is inserted.
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
Professor Hisham Mehanna
Supported by
NIHR Health Technology Assessment (HTA) programme
NIHR Clinical Research Network: Cancer
University of Birmingham
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040