Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI.

Conditions
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Colorectal Neoplasms, Neoplasm Metastases, Hepatic Neoplasms

Intervention / Treatment
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* Other: Diffusion Weighted MRI scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diffusion Weighted MRI scan<br>Patients who are enrolled in the study will undergo an additional diffusion weighted MRI (T2W, DWI and ADC sequences) of the liver. | Other: Diffusion Weighted MRI scan<br>* Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years after last recruit (end of trial) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 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 | 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 | 5 years after last recruit (end of trial) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Neoplasms, Neoplasm Metastases, Magnetic Resonance Imaging, Diffusion Weighted MRI, Hepatic Neoplasms, Tumors, Neoplasms, Rectal