Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorImperial College London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Have had a previous colorectal malignancy
Have metastatic disease
Have a synchronous second malignancy
Are contraindicated for MRI
Trial design
Design model
Single group
Treatments tested in this trial
Diffusion Weighted MRI scan
Other interventionLiver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.
Treatment groups
282 Participants
are divided into 1 treatment groupGroup A: Diffusion Weighted MRI scanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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, 3yr4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Imperial College London
Lead sponsor
Pelican Cancer Foundation
Collaborator
Source ClinicalTrials.gov