Clinical trial NCT02246634: Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)
Official title: Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Neoplasm Metastases
Hepatic Neoplasms
Keywords: Colorectal Neoplasms
Neoplasm Metastases
Magnetic Resonance Imaging
Diffusion Weighted MRI
Hepatic Neoplasms
Tumors
Neoplasms, Rectal
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Pelican Cancer Foundation
First posted: 2014-09-23
Enrollment: 282
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.
timeFrame: 5 years after last recruit (end of trial)
Secondary outcomes:
measure: To compare the baseline risk factors of the primary tumour against the timing and pattern of metastatic disease relapse in the liver.
timeFrame: 5 years after last recruit (end of trial)
measure: To determine the sensitivity and specificity of DW-MRI as a screening method for liver lesions in patients with high risk colorectal cancer.
timeFrame: 5 years after last recruit (end of trial)
measure: To describe the cancer specific disease free survival and overall survival outcomes in patients with and without liver metastases.
timeFrame: 6mth, 12mth, 18mth, 2yr, 3yr
measure: To characterise the patients diagnosed through screening with liver metastasis in the SERENADE study using the Fong criteria.
timeFrame: 5 years after last recruit (end of trial)
measure: To describe the impact of MR screening on treatment received by patients who are diagnosed with liver metastases.
timeFrame: 5 years after last recruit (end of trial)
Other outcomes:
Locations:
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
state: Cheshire
city: Burton upon Trent
country: United Kingdom
facility: Queen's Hospital
state: Derbyshire
city: Chelmsford
country: United Kingdom
facility: Broomfield Hospital
state: Essex
city: Bolton
country: United Kingdom
facility: Royal Bolton Hospital
state: Greater Manchester
city: Gillingham
country: United Kingdom
facility: Medway Maritime Hospital
state: Kent
city: Wythenshawe
country: United Kingdom
facility: University Hospital of South Manchester & Manchester Royal Infirmary
state: Manchester
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Hospital
state: Merseyside
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
state: Staffordshire
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital
state: Wales
city: Nuneaton
country: United Kingdom
facility: George Eliot Hospital
state: Warwickshire
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
state: Wiltshire
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
Study officials:
affiliation: Imperial College London
name: Gina Brown
role: PRINCIPAL_INVESTIGATOR
References: