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| Name | Class |
|---|---|
| Pelican Cancer Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diffusion Weighted MRI scan | Experimental | Patients who are enrolled in the study will undergo an additional diffusion weighted MRI (T2W, DWI and ADC sequences) of the liver. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion Weighted MRI scan | Other | Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| To determine the sensitivity and specificity of DW-MRI as a screening method for liver lesions in patients with high risk colorectal cancer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Martin | Contact | +44 (0) 7749 655 817 | c.martin1@imperial.ac.uk | |
| Syvella Ellis | Contact | +44 (0) 7732 315 234 | giclinicaltrials@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Gina Brown | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macclesfield District General Hospital | Recruiting | Macclesfield | Cheshire | SK10 3BL | United Kingdom |
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% 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) |
| 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 |
| 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) |
| 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) |
| Queen's Hospital | Not yet recruiting | Burton-on-Trent | Derbyshire | DE13 0RB | United Kingdom |
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| Broomfield Hospital | Recruiting | Chelmsford | Essex | CM1 7ET | United Kingdom |
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| Royal Bolton Hospital | Recruiting | Bolton | Greater Manchester | BL4 0JR | United Kingdom |
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| Medway Maritime Hospital | Recruiting | Gillingham | Kent | ME7 5NY | United Kingdom |
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| University Hospital of South Manchester & Manchester Royal Infirmary | Recruiting | Wythenshawe | Manchester | M23 9LT | United Kingdom |
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| Royal Liverpool Hospital | Recruiting | Liverpool | Merseyside | L7 8XP | United Kingdom |
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| Royal Stoke University Hospital | Recruiting | Stoke-on-Trent | Staffordshire | ST4 6QG | United Kingdom |
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| Royal Marsden Hospital | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
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| Royal Gwent Hospital | Recruiting | Newport | Wales | NP20 2UB | United Kingdom |
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| George Eliot Hospital | Recruiting | Nuneaton | Warwickshire | CV10 7DJ | United Kingdom |
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| Salisbury District Hospital | Recruiting | Salisbury | Wiltshire | SP2 8BJ | United Kingdom |
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| Queen Alexandra Hospital | Recruiting | Portsmouth | United Kingdom |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| D008113 | Liver Neoplasms |
| D009369 | Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
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