Colorectal Neoplasms, Hepatic Neoplasms, Neoplasm Metastases
Conditions
Keywords
Colorectal Neoplasms, Neoplasm Metastases, Magnetic Resonance Imaging, Diffusion Weighted MRI, Hepatic Neoplasms, Tumors, Neoplasms, Rectal
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.
Interventions
OTHERDiffusion Weighted MRI scan
Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.
Sponsors
Pelican Cancer Foundation
Imperial College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
United Kingdom
Contacts
Primary ContactCaroline Martin
Backup ContactSyvella Ellis
Outcome results
None listed