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

Imperial College London

Status: Enrolling

Conditions: Hepatic Neoplasms; Neoplasm Metastases; Colorectal Neoplasms

Treatments: Other: Diffusion Weighted MRI scan

Study type: Interventional

Funder types: Other

Identifiers

NCT02246634

DOCUMAS: 17HH4153

Details and patient eligibility

About

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.

Full 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.

Enrollment: 282 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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282 participants in 1 patient group

Diffusion Weighted MRI scan

Experimental group

Description:

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

Treatment:

Other: Diffusion Weighted MRI scan