ElaTION
Research type
Research Study
Full title
The efficacy and cost effectiveness of Real Time Ultrasound Elastography in the investigation of thyroid nodules and the diagnosis of thyroid cancer.
IRAS ID
142485
Contact name
Hisham Mehanna
Contact email
Sponsor organisation
University of Birmingham
Research summary
Thyroid lumps (nodules) are very common. About 1 in 20 people will feel a thyroid lump at some time in their life. About half the population will have lumps in their thyroid if examined by ultrasound. About 1 in 20 thyroid lumps are cancerous. Currently, ultrasound-guided fine needle aspiration is recommended for the diagnosis of thyroid nodules.
The ElaTION study is a pragmatic multicentre randomised trial comparing the use of Real Time Elastography (RTE) in conjunction with ultrasound to guide fine needle aspiration cytology FNAC (the intervention) with conventional ultrasound-only guided FNAC (current practice–comparator).
RTE is a technology that can be used in conjunction with routine ultrasound examination, and may help differentiate benign from malignant nodules. In small studies, this technology has been shown to have a high accuracy; it may therefore be possible that using RTE in addition to ultrasound-needle biopsy, may make the biopsy more accurate. This may reduce the number of biopsies required to obtain a definitive diagnosis.
Patients over 18 years old or over with a thyroid nodule detected by the clinician or identified incidentally by imaging performed for non-thyroid pathology are eligible for the study.
The study will take place in hospital trusts with radiologists who are trained in using RTE.
Patients will be asked to enter the study by their radiologist or the research nurse at their trust and will remain in the study for 1 year from recruitment. This will allow time for a definitive diagnosis to be reached and for the patient to undergo surgery to remove the nodule if necessary. Patients will be asked to complete validated questionnaires at 4 time points during the study and will also be asked for consent to collect tissue samples and a blood sample.
The study is funded by a grant from the National Institute for Health Research.REC name
South Central - Berkshire Research Ethics Committee
REC reference
14/SC/1206
Date of REC Opinion
22 Oct 2014
REC opinion
Further Information Favourable Opinion