Condition category
Cancer
Date applied
24/07/2012
Date assigned
25/07/2012
Last edited
16/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Prof Stuart Taylor

ORCID ID

Contact details

University College London
University College London Hospitals
Specialist X Ray Department
235 Euston Road
London
NW1 2BU
United Kingdom
stuart.taylor1@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comprehensive staging of newly diagnosed colorectal cancer: prospective multi-centre comparison of whole body Magnetic Resonance Imaging with standard diagnostic imaging pathways

Acronym

Streamline C

Study hypothesis

To evaluate whether early whole body magnetic resonance Imaging (WB-MRI) increases per patient sensitivity for metastasis in colorectal cancer compared to standard NICE-approved diagnostic pathways.

More details can be found at http://www.hta.ac.uk/project/2804.asp

Ethics approval

Camden and Islington Research Ethics Committee, 20 August 2012, ref: 12/LO/1176

Study design

Multicentre comparison

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please contact ctc.streamlineC@ucl.ac.uk to request a patient information sheet

Condition

Colorectal cancer

Intervention

5. There are no treatment arms, every patient will receive a whole body MRI as part of the trial which takes about an hour. Aside from attending for the WB-MRI scan, patients shouldn’t have to attend for any extra visits. All patients will be asked to complete quality of life forms (EQ-5D) at 0, 3, 6 and 9 months post staging. As part of the health economics portion of the trial, all patients will also be asked to complete patient diaries which will collect information about visits to the GP and hospital and about other medical tests and treatment for a year post staging. As part of the health psychology portion of the trial, 25 patients will take part in an interview (30 minutes) and 75 patients will be given questionnaires complete about their experience of staging at 0, 1, 3, 6, 9, and 12 months post staging. Follow-up CRF’s will be completed for a year post-staging but there are no trial specific visits, this data is collected for the health economic portion of trial.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Per patient sensitivity for metastasis detection by whole body MRI (WB-MRI) compared to standard staging pathways in newly diagnosed colorectal cancer

Secondary outcome measures

1. The time and test number taken to reach, and the nature of, the first major treatment decision based on WB-MRI in comparison to standard staging pathways.
2. Diagnostic accuracy of WB-MRI and conventional staging pathways for local tumour staging and detection of metastasis in comparison to an expert derived consensus reference standard.
3. Lifetime incremental cost and cost-effectiveness of staging using WB-MRI compared to standard diagnostic pathways.
4. Patient experience of staging using WB-MRI in comparison to standard diagnostic pathways and priorities placed by patients on differing attributes related to competing staging pathways.
5. Inter-observer variability in WB-MRI analysis and affect of diagnostic confidence on staging accuracy.
6. Diagnostic accuracy of limited T1 and diffusion weighted sequences compared to full multi-sequence WB-MRI protocols.

Overall trial start date

01/10/2012

Overall trial end date

01/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (18 or over) with histologically proven or suspected colorectal cancer referred for staging.
2. Suspicion of colorectal cancer defined as: Presence of a mass highly suspicious for colorectal cancer on endoscopy, barium enema, CT colonography or other imaging which triggers staging investigations.
3. Patient must have given written informed consent and be willing to comply with the protocol intervention and follow up.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

322

Participant exclusion criteria

1. Any psychiatric or other disorder likely to impact on informed consent
2. Evidence of severe or uncontrolled systemic disease which make it undesirable for the patient to participate in the trial
3. Pregnancy
4. Contraindications to MRI (e.g. cardiac pacemaker, severe claustrophobia, inability to lie flat)
5. Polyp cancer (because metastatic disease in these patients is vanishingly rare)

Recruitment start date

01/10/2012

Recruitment end date

01/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Cancer Research UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom

Sponsor type

University/education

Website

http://www.ctc.ucl.ac.uk/

Funders

Funder type

Not defined

Funder name

NIHR Helath Technology Assessment Programme - HTA (UK) ref: 10/68/01

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