Condition category
Cancer
Date applied
23/01/2015
Date assigned
02/02/2015
Last edited
05/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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

Type

Public

Primary contact

Ms Pam Shuttleworth

ORCID ID

Contact details

St James's University Hospital
Level -1
Bexley Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom

Type

Scientific

Additional contact

Dr Robin Prestwich

ORCID ID

http://orcid.org/0000-0002-7872-2826

Contact details

St James's University Hospital
Level 4 Bexley Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CO10/9645

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

Acronym

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

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Radiotherapy for head and neck cancer

Intervention

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

Procedure/Surgery

Phase

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

25/07/2011

Overall trial end date

07/05/2013

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

25/07/2011

Recruitment end date

01/05/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St James's University Hospital
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Leeds Teaching Hospitals NHS Trust

Sponsor details

Research and Development
34 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Leeds Teaching Hospitals Charitable Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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: http://www.ncbi.nlm.nih.gov/pubmed/25885109
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26530182

Publication citations

Additional files

Editorial Notes