Plain English Summary
Background and study aims:
We are carrying out a study to see if we can improve the imaging of colorectal cancer using a type of Computed Tomography (CT) scan known as perfusion CT. This type of scan can measure blood supply to tumours and we hope to use this information to improve our understanding of how tumours may behave and so future treatment.
Who can participate?
Men and women, aged 18 years or over, with suspected or proven colorectal cancer.
What does the study involve?
Participants will undergo an additional CT scan, which lasts approximately 2 minutes. This is carried out at the same time as the usual CT scan that participants would normally have. During the scan a dye will be administered through a needle in the participant's arm. Also, a bowel relaxant called buscopan will be given by injection to achieve a better quality scan image. Participants will continue to attend clinic visits for the first three years following the additional scan.
What are the possible benefits and risks of participating?
There may be no immediate benefit to those taking part. However the information we get from the study will help us to improve scan imaging of future patients and to possibly assess future cancer treatment. The main risk associated with the study is the increased radiation dose that comes with receiving an additional CT scan. The dye that is administered during the scan may cause mild side effects including nausea and vomiting, or a rash. An allergic reaction occurs rarely and may require drug treatment. Buscopan commonly causes a dry mouth. Other side effects are rare and include fast beating heart, shortness of breath and skin reactions.
Where is the study run from?
Bradford Royal Infirmary
Guy;s and St Thomas; Hospital, London
Western General, Edinburgh
University Hospital of North Staffordshire
Churchill Hospital, Oxford
Queen Alexandra Hospital, Portsmouth
Royal Cornwall Hospital, Truro
Northern General Hospital, Sheffield
Ninewells Hospital, Dundee
St James' University Hospital, Leeds
When is the study starting and how long is it expected to run for?
The study began recruiting in November 2011, and participants will be enrolled for 12-15 months. Recruitment will end in early 2013.
Who is funding the study?
National Institute for Health Research - Health Technology Assessment Programme
Who is the main contact?
Improving the prediction of metastatic disease in primary colorectal cancer: prospective multicentre evaluation of a prognostic model of conventional predictive variables and novel variables derived from perfusion computed tomography
To improve the prediction of metastatic disease in patients with colorectal cancer by developing a prognostic model based on disease free survival, that is superior to current practice, via prospective evaluation of both conventional predictive variables and novel variables derived from perfusion computed tomography (CT).
On 15/05/2012 the overall trial end date was changed from 31/05/2012 to 31/12/2012.
First MREC, 20/01/2011, ref: 10/H0713/84
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
1. Perfusion computed tomography (CT) sequence
2. An additional perfusion CT sequence during the standard contrast-enhanced staging CT
3. Follow Up Length: 36 months
Primary outcome measures
1. To improve the prediction of metastatic disease in patients with colorectal cancer by developing a p
2. Measured at 3 and 5 years for each individual patient
Secondary outcome measures
No secondary outcome measures
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Patients with suspected or proven (via optical colonoscopy and biopsy) colorectal cancer attending for pre-operative staging CT
2. Suspicion of colorectal cancer defined as:
2.1. Presence of a mass highly suspicious for colorectal cancer on barium enema, CT colonography or other imaging
2.2. Large bowel obstruction
2.3. Elevated serum CEA
3. Ability to provide informed written consent
4. Aged 18 years or over
5. Male or female participants
Target number of participants
Planned Sample Size: 370; UK Sample Size: 370
Participant exclusion criteria
1. Inability to provide informed written consent
3. Renal impairment defined as serum creatinine >1150mmol/L
4. Previous iodinated contrast allergy
5. Inability to cannulate
6. Inability to lie flat
7. Weight greater than 200 kg (maximum weight capacity of CT scanner is 200 kg)
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
ISD Cancer Clinical Trials Team
King's College London
NIHR - Health Technology Assessment Programme (HTA)
Funding Body Type
Funding Body Subtype
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
Results - basic reporting