SERENADE: Screening for synchronous metastases in colorectal cancer using Hepatic Diffusion weighted MRI.

Study ID: 17059
Short Title: SERENADE
Trust Name: SFT
Recruitment Site: Salisbury District Hospital
Disease Area: Colorectal cancer
Phase: II
Expected End Date: 31/12/2024
Postcode: SP2 8BJ
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

1. High risk primary colorectal cancer (as determined by CT or MRI). 2. CT which is negative for, or no confirmatory evidence of, metastatic disease . 3. Patient aged over 18 years

1. Patients who are unable to give consent, who withhold consent or who withdraw consent will be excluded. 2. Patient is undergoing active treatment or follow-up for another malignancy (excluding basal cell carcinoma). 3. Patient has a contraindication to CT or MRI (e.g. intraocular metal fragments, pacemaker, severe claustrophobia), iodine or gadolinum based contrast agents (documented allergy to iodine, renal impairment with GFR < 30mL/min) 4. Patients who are pregnant or breast feeding. 5. Patients who have received systemic treatment for colorectal cancer. 6. Patients with any metastatic disease.

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. 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.

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