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

Colorectal Neoplasms Clinical Trial

— SERENADE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02246634
• Other study ID #: DOCUMAS: 17HH4153
• Status: Recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2029

Study information

• Verified date: August 2023
• Source: Imperial College London
• Contact: Caroline Martin
• Phone: +44 (0) 7749 655 817
• Email: c.martin1[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 282
• Est. completion date: December 2029
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Hepatic Neoplasms
• Liver Neoplasms
• Neoplasm Metastases
• Neoplasm Metastasis
• Neoplasms

Intervention

Other:
• Diffusion Weighted MRI scan
Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.

Locations

Country	Name	City	State
United Kingdom	Royal Bolton Hospital	Bolton	Greater Manchester
United Kingdom	Queen's Hospital	Burton upon Trent	Derbyshire
United Kingdom	Broomfield Hospital	Chelmsford	Essex
United Kingdom	Medway Maritime Hospital	Gillingham	Kent
United Kingdom	Royal Liverpool Hospital	Liverpool	Merseyside
United Kingdom	Macclesfield District General Hospital	Macclesfield	Cheshire
United Kingdom	Royal Gwent Hospital	Newport	Wales
United Kingdom	George Eliot Hospital	Nuneaton	Warwickshire
United Kingdom	Queen Alexandra Hospital	Portsmouth
United Kingdom	Salisbury District Hospital	Salisbury	Wiltshire
United Kingdom	Royal Stoke University Hospital	Stoke-on-Trent	Staffordshire
United Kingdom	Royal Marsden Hospital	Sutton	Surrey
United Kingdom	University Hospital of South Manchester & Manchester Royal Infirmary	Wythenshawe	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Pelican Cancer Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)