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

Not Applicable

Recruiting

• Conditions: Neoplasm Metastases; Colorectal Neoplasms; Hepatic Neoplasms
• Interventions: Other: Diffusion Weighted MRI scan

• Registration Number: NCT02246634
• Lead Sponsor: Imperial College London

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17
• Primary Completion: 2026-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

1. Have a high risk primary colorectal malignancy
2. Have a negative CT or includes no confirmatory evidence of liver metastases
3. Is able to undergo treatment if liver metastasis is found
4. Have provided written informed consent to participate in the study
5. Be aged 16 years or over

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Exclusion Criteria

1. Have had a previous colorectal malignancy
2. Have metastatic disease
3. Have a synchronous second malignancy
4. Are contraindicated for MRI
5. Has a T3b or below low rectal tumour without EMVI or N1c

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diffusion Weighted MRI scan	Diffusion Weighted MRI scan	Patients who are enrolled in the study will undergo an additional diffusion weighted MRI (T2W, DWI and ADC sequences) of the liver.

Primary Outcome Measures

Name	Time	Method
Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.	5 years after last recruit (end of trial)	Proportion of additional patients diagnosed with liver metastases on DW MRI compared with CT.

Secondary Outcome Measures

Name	Time	Method
To compare the baseline risk factors of the primary tumour against the timing and pattern of metastatic disease relapse in the liver.	5 years after last recruit (end of trial)	% of patients diagnosed with liver metastases according to known prognostic risk factors
To determine the sensitivity and specificity of DW-MRI as a screening method for liver lesions in patients with high risk colorectal cancer.	5 years after last recruit (end of trial)	% 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.
To describe the cancer specific disease free survival and overall survival outcomes in patients with and without liver metastases.	6mth, 12mth, 18mth, 2yr, 3yr	Survival and recurrence outcomes according to presence or absence of liver metastases
To describe the impact of MR screening on treatment received by patients who are diagnosed with liver metastases.	5 years after last recruit (end of trial)	Proportion of patients undergoing curative treatment and methods of treatment
To characterise the patients diagnosed through screening with liver metastasis in the SERENADE study using the Fong criteria.	5 years after last recruit (end of trial)	Fong score of all patients with liver metastases

Trial Locations

Locations (13)

Broomfield Hospital; 🇬🇧 Chelmsford, Essex, United Kingdom

Medway Maritime Hospital; 🇬🇧 Gillingham, Kent, United Kingdom

University Hospital of South Manchester & Manchester Royal Infirmary; 🇬🇧 Wythenshawe, Manchester, United Kingdom

Macclesfield District General Hospital; 🇬🇧 Macclesfield, Cheshire, United Kingdom

Queen Alexandra Hospital; 🇬🇧 Portsmouth, United Kingdom

Queen's Hospital; 🇬🇧 Burton upon Trent, Derbyshire, United Kingdom

Royal Gwent Hospital; 🇬🇧 Newport, Wales, United Kingdom

Royal Liverpool Hospital; 🇬🇧 Liverpool, Merseyside, United Kingdom

Royal Bolton Hospital; 🇬🇧 Bolton, Greater Manchester, United Kingdom

George Eliot Hospital; 🇬🇧 Nuneaton, Warwickshire, United Kingdom

Royal Stoke University Hospital; 🇬🇧 Stoke-on-Trent, Staffordshire, United Kingdom

Royal Marsden Hospital; 🇬🇧 Sutton, Surrey, United Kingdom

Salisbury District Hospital; 🇬🇧 Salisbury, Wiltshire, United Kingdom