Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)
Recruiting · NCT02246634 · Interventional (participants receive a specific treatment) · Lead sponsor: Imperial College London
View the official record on ClinicalTrials.gov →Interventions studied
Diffusion Weighted MRI scan
What this trial is about
Eligible patients with high risk colorectal malignancy (T3/4, spread greater than 5mm, EMVI positive) will have additional surveillance of breath hold T1, T2 and DW-MRIs (no IV contrast) post surgery six monthly for three years. Findings of liver MRIs as reported by radiology PI will be shared with their local MDT who make decisions as appropriate, including the management of any identified liver metastases, according to local protocol.
Who can take part
Age range
16 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Have a high risk primary colorectal malignancy
- Have a negative CT or includes no confirmatory evidence of liver metastases
- Is able to undergo treatment if liver metastasis is found
- Have provided written informed consent to participate in the study
- Be aged 16 years or over
Exclusion criteria
- Have had a previous colorectal malignancy
- Have metastatic disease
- Have a synchronous second malignancy
- Are contraindicated for MRI
- Has a T3b or below low rectal tumour without EMVI or N1c
Where it is running
13 locations listed.
- Queen Alexandra Hospital - Portsmouth, United Kingdom
- Macclesfield District General Hospital - Macclesfield, Cheshire, United Kingdom
- Queen's Hospital - Burton-on-Trent, Derbyshire, United Kingdom
- Broomfield Hospital - Chelmsford, Essex, United Kingdom
- Royal Bolton Hospital - Bolton, Greater Manchester, United Kingdom
- Medway Maritime Hospital - Gillingham, Kent, United Kingdom
- University Hospital of South Manchester & Manchester Royal Infirmary - Wythenshawe, Manchester, United Kingdom
- Royal Liverpool Hospital - Liverpool, Merseyside, United Kingdom
- Royal Stoke University Hospital - Stoke-on-Trent, Staffordshire, United Kingdom
- Royal Marsden Hospital - Sutton, Surrey, United Kingdom
- Royal Gwent Hospital - Newport, Wales, United Kingdom
- George Eliot Hospital - Nuneaton, Warwickshire, United Kingdom
- Salisbury District Hospital - Salisbury, Wiltshire, United Kingdom