Condition category
Cancer
Date applied
10/08/2011
Date assigned
10/08/2011
Last edited
09/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
Southampton General
Ninewells Hospital, Dundee
York Hospital
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?
Michelle McDermaid
michelle.mcdermaid@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Michelle McDermaid

ORCID ID

Contact details

ISD Cancer Clinical Trials Team
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9423

Study information

Scientific title

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

Acronym

PROSPECT

Study hypothesis

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.

Ethics approval

First MREC, 20/01/2011, ref: 10/H0713/84

Study design

Non-randomised, interventional

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

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

Condition

Colorectal cancer

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

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

31/01/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 370; UK Sample Size: 370

Participant exclusion criteria

1. Inability to provide informed written consent
2. Pregnancy
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

01/11/2011

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

ISD Cancer Clinical Trials Team
Edinburgh
EH12 9EB
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

The Strand
London
WC2R 3LS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.kcl.ac.uk

Funders

Funder type

Government

Funder name

NIHR - Health Technology Assessment Programme (HTA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

Publication citations

Additional files

Editorial Notes