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.
A phase II multicentre, interventional study to determine if additional staging at diagnosis with liver DW-MRI will diagnose more synchronous metastases than CT alone in patients with high risk colorectal cancer. Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local policy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
282
Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.
Macclesfield District General Hospital
Macclesfield, Cheshire, United Kingdom
RECRUITINGQueen's Hospital
Burton-on-Trent, Derbyshire, United Kingdom
NOT_YET_RECRUITINGBroomfield Hospital
Chelmsford, Essex, United Kingdom
RECRUITINGRoyal Bolton Hospital
Bolton, Greater Manchester, United Kingdom
RECRUITINGMedway Maritime Hospital
Gillingham, Kent, United Kingdom
RECRUITINGUniversity Hospital of South Manchester & Manchester Royal Infirmary
Wythenshawe, Manchester, United Kingdom
RECRUITINGRoyal Liverpool Hospital
Liverpool, Merseyside, United Kingdom
RECRUITINGRoyal Stoke University Hospital
Stoke-on-Trent, Staffordshire, United Kingdom
RECRUITINGRoyal Marsden Hospital
Sutton, Surrey, United Kingdom
RECRUITINGRoyal Gwent Hospital
Newport, Wales, United Kingdom
RECRUITING...and 3 more locations
Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.
Proportion of additional patients diagnosed with liver metastases on DW MRI compared with CT.
Time frame: 5 years after last recruit (end of trial)
To compare the baseline risk factors of the primary tumour against the timing and pattern of metastatic disease relapse in the liver.
% of patients diagnosed with liver metastases according to known prognostic risk factors
Time frame: 5 years after last recruit (end of trial)
To determine the sensitivity and specificity of DW-MRI as a screening method for liver lesions in patients with high risk colorectal cancer.
% lesions suspected as metastatic on DW MRI confirmed by subsequent 'gold standard' of contrast enhanced MRI and/or surgical resection, and/or progressive enlargement of the lesion.
Time frame: 5 years after last recruit (end of trial)
To describe the cancer specific disease free survival and overall survival outcomes in patients with and without liver metastases.
Survival and recurrence outcomes according to presence or absence of liver metastases
Time frame: 6mth, 12mth, 18mth, 2yr, 3yr
To characterise the patients diagnosed through screening with liver metastasis in the SERENADE study using the Fong criteria.
Fong score of all patients with liver metastases
Time frame: 5 years after last recruit (end of trial)
To describe the impact of MR screening on treatment received by patients who are diagnosed with liver metastases.
Proportion of patients undergoing curative treatment and methods of treatment
Time frame: 5 years after last recruit (end of trial)
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