Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Mr Andrew Palmer


Contact details

Birmingham Clinical Trials Unit (BCTU)
Institute of Applied Health Research
College of Medical and Dental Sciences
Public Health Building
University of Birmingham
B15 2TT
United Kingdom
+44 (0)121 415 9965

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The efficacy and cost effectiveness of real time ultrasound elastography in the investigation of thyroid nodules and the diagnosis of thyroid cancer



Study hypothesis

The aim of this study is to compare 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).

Ethics approval

NREC Committee South Central- Berkshire, 10/10/2014, ref: 14/SC/1206

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Topic: Cancer, Ear, nose and throat; Subtopic: Head and Neck Cancer, Ear (all Subtopics); Disease: Endocrine, Head and Neck


Intervention arm- Real-time ultrasound elastography – guided FNAC. RTE is a technology that can be added at the same time as the routine ultrasound examination, and may help differentiate benign from malignant nodules based on the compression characteristics of the two.; Follow Up Length: 12 month(s)

Intervention type



Drug names

Primary outcome measure

Primary outcome measure as of 14/02/2017:
The proportion of patients who have a non-diagnostic (Thy1) cytology result following the first FNAC.

Original primary outcome measure:
The rate of benign histology result following thyroid surgery, compared between the RTE-FNAC arm and the conventional US-FNAC arm.

Secondary outcome measures

Secondary outcome measures as of 14/02/2017:
1. Number of FNACs required to obtain definitive diagnosis
2. Time from first FNAC to obtaining a definitive diagnosis
3. The proportion of patients with benign histology results following thyroidectomy
4. Proportion of patients who have thyroidectomy
5. Accuracy of a cytology results for first FNAC and repeated FNAC in relation to overall definitive diagnosis;
6. Accuracy of an imaging assessment on ultrasound (with or without RTE) alone diagnostic protocol in relation to overall definitive diagnosis
7. Patient reported outcome measures of depression and anxiety, pain, and quality of life: the Hospital Anxiety and Depression rating scale (HADS), Visual Analogue Pain Score (VAPS) and EQ-5D quality of life score
8. Radiologist report of whether RTE had contributed to the radiologist’s decisions, how easy they found using RTE, and whether they found it helpful above using US-alone in predicting malignancy
9. Complication rate from any thyroidectomy at 30-days and 6-months post-surgery – to include haematoma and temporary hypocalcaemia rate at 30 days and vocal cord palsy and permanent hypocalcaemia at 6 months post-operative
10. Resource usage for consultant time and diagnostic testing procedures and subsequent management including consultations and surgical treatments

Original secondary outcome measures:
1. Overall number of FNAC's Required and time to obtain a definitive diagnosis in each arm
2. Non-diagnostic cytology (Thy1) rate for the first FNAC undertaken in each patient
3. Resource use for consultation time and diagnostic testing procedures and quality of life (EQ-5D)
4. Predictive value of a benign (Thy2) cytology results for first FNAC and repeated FNAC in relation to overall definitive diagnosis for RTE-FNAC and conventional US-FNAC
5. Patients reported anxiety immediately before and after US FNAC, immediately before each consultation for results of US FNA or surgery and at 6 and 12 months from initial US FNAC
6. Radiologist survey-completed by Radiologists at the end of the procedure to identify whether radiologists found US or RTE had contributed to their decision, ease of use, and their prediction of malignancy of the nodule using RTE or US features alone
7. Agreement rates for RTE between local operator and RTE or US features alone
8. Patient reported pain (by Visual analogue score) at procedure
9. Complication rate from any thyroidectomy- haematoma rate, vocal cord palsy at 6 months, permanent hypocalcaemia rate at 6 months
10. Cost-benefit analysis

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Patients with single or multiple thyroid nodules whether solid, cystic or mixed, undergoing investigation who have not undergone previous FNAC within the last 6 months
2. Aged 18 or over
3. Patient able and willing to give written informed consent

Participant type


Age group




Target number of participants

Planned Sample Size: 968; UK Sample Size: 968

Participant exclusion criteria

1. Patients who have undergone previous thyroid FNAC in the last 6 months.
2. Patients with a bleeding diathesis that precludes FNAC
3. Patients with a needle phobia. 
4. Pregnant patients 
5. Patients with purely cystic nodules or with recent haemorrhage, with no solid component

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials Unit (University of Birmingham)
B15 2TT
United Kingdom

Sponsor information


University of Birmingham

Sponsor details

Institute for Cancer Studies
B15 2TT
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date


Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/10/2018: Intention to publish date added. 12/01/2018: The recruitment end date has been updated from 30/11/2017 to 30/09/2018. The overall trial end date has been updated from 30/11/2017 to 30/03/2020. 14/02/2017: The following changes have been made to the record: 1. The target number of participants has been updated from 1000 to 968 2. Within "the last 6 months" has been added to the first inclusion criteria and exclusion criteria 3. The outcome measures have been updated 30/11/2016: The study contact has been changed from Mrs Sarah Khan to Mr Andrew Palmer.