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 shouldnt 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 CRFs 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 measure
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
01/01/2019
Reason abandoned (if study stopped)
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
Total final enrolment
370
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
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
Basic results (scientific)
Publication list
2019 result in: https://www.ncbi.nlm.nih.gov/pubmed/31080095 (added 14/05/2019)
2019 comparative results against ISRCTN50436483 in: https://www.ncbi.nlm.nih.gov/pubmed/31855148 (added 20/12/2019)