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

Plain English Summary

Background and study aims
Radiotherapy is a treatment involving the use of high-energy radiation. It is commonly used to treat advanced cancers of the head and neck, aiming to cure while preserving patients’ quality of life including their ability to speak and swallow. In order to reduce the potentially major side effects of treatment, it is essential that the highest doses of radiotherapy are targeted to the main bulk of the tumour. At present a computerized tomography (CT) scan is used by the cancer specialist to identify the tumour for planning the radiotherapy treatment. We know that other types of scan including magnetic resonance imaging (MRI) and positron emission tomography (PET) scans are better than CT scans at showing areas invaded by the cancer. However, radiotherapy cannot be directly planned on these types of scans. The aim of this study is to explore whether PET and MRI scans can be combined with CT scans to more accurately identify the tumour target. In addition, this study will explore whether PETCT and MRI scans may be used to adjust radiotherapy to how well a tumour is responding during a course of radiotherapy.

Who can participate?
Patients aged 18 or over with cancers of the head and neck undergoing a course of radiotherapy.

What does the study involve?
All patients within the study will undergo a PETCT and an MRI scan prior to starting treatment as part of the study. A subgroup of patients will undergo additional imaging at two timepoints during the course of their radiotherapy.

What are the possible benefits and risks of participating?
If the radiotherapy planning process can be improved in these ways, we hope future patients will benefit by more chance of cure with a reduction in the side effects of treatment. The participants’ standard treatment will not be affected by their participation in the study.

Where is the study run from?
St James's University Hospital (UK).

When is the study starting and how long is it expected to run for?
From July 2011 to May 2013.

Who is funding the study?
Leeds Teaching Hospitals Charitable Foundation (UK).

Who is the main contact?
Pam Shuttleworth
Robin Prestwich

Trial website

Contact information



Primary contact

Ms Pam Shuttleworth


Contact details

St James's University Hospital
Level -1
Bexley Wing
Beckett Street
United Kingdom



Additional contact

Dr Robin Prestwich


Contact details

St James's University Hospital
Level 4 Bexley Wing
Beckett Street
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Assessment of the use of co-registered 18-fluorodeoxyglucose-PET-CT and MRI for radiotherapy planning in locally advanced head and neck squamous cell carcinoma: a pilot study


Study hypothesis

An imaging study, with no change made to patients' treatment:
1. To explore whether PET and MRI scans can be combined with CT scans to more accurately identify the tumour target for radiotherapy planning
2. To explore whether PET-CT and MRI scans may be used to detect alterations in the tumour during a course of radiotherapy, to allow the future design of studies to look at adapting treatment according to tumour response

Ethics approval

National Research Ethics Service, Yorkshire and Humber (UK), 25/07/2011, reference: 11/YH/0212

Study design

Single-centre pilot study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet


Radiotherapy for head and neck cancer


1. Patients will have an MRI scan and an 18-fluorodeoxyglucose (18FDG)-PET-CT scan in a radiotherapy mask before the start of radiotherapy treatment
2. A subset of patients within the study will have repeat MRI and 18-FDG-PET-CT scans after 2 weeks and 4 weeks of radiotherapy treatment

Intervention type



Drug names

Primary outcome measures

Accuracy of imaging with a 18FDG-PET-CT and MRI for identification of head and neck
tumours for radiotherapy planning, assessed with intraobserver and interobserver comparison of delineation of tumour target by radiologists and radiation oncologists using PET, MRI and CT imaging; analysis will be done when recruitment is complete

Secondary outcome measures

1. To determine whether CT scan routinely used to plan radiotherapy can be accurately merged with an MRI scan
2. To determine the feasibility of performing MRI and PET-CT imaging during a course of radiotherapy
3. To identify the most useful timepoints for imaging during radiotherapy to track tumour changes
4. To determine whether changes on MRI and PET-CT taken during radiotherapy could be used to improve the radiotherapy plan during treatment

These endpoints will be evaluated with quantitative contour comparison tools. Analysis will be done when recruitment is complete.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Age ≥18 years old
2. WHO performance status 0-2
3. Histologically proven squamous cell carcinoma of the head and neck region
4. Clinical decision made to proceed with a course of radiotherapy of curative intent of 66-70Gy in 33-35 fractions over 6.5–7 weeks with or without concurrent chemotherapy
5. Measurable primary tumour and/or locoregional metastatic lymph nodes on preradiotherapy imaging
6. Able to provide written informed consent
7. Able to lie flat for 1 hour
8. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal

Participant type


Age group




Target number of participants

15 patients

Participant exclusion criteria

1. Hypersensitivity to fluorine-18 FDG
2. Hypersensitivity to iodinated contrast media or gadolinium
3. Poorly controlled diabetes
4. Acute renal failure or moderate renal impairment (estimated glomerular filtration rate < 30 mL/min)
5. Contraindication to MRI imaging, including cardiac pacemaker or presence of MRI incompatible metalwork
6. Claustrophobia precluding MRI imaging
7. Uncontrolled pain
8. Urinary incontinence
9. Female patients must not be pregnant
10. Breastfeeding
11. Serious psychiatric comorbidity

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

St James's University Hospital
United Kingdom

Sponsor information


Leeds Teaching Hospitals NHS Trust

Sponsor details

Research and Development
34 Hyde Terrace
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Leeds Teaching Hospitals Charitable Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Aim to publish outcomes in a peer reviewed journal in 2015/6

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in:
2015 results in:

Publication citations

Additional files

Editorial Notes