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

NCT02246634 | Recruiting DMC

• 1 other identifier: DOCUMAS: 17HH4153
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 13

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.

Conditions

Colorectal Neoplasms; Neoplasm Metastases; Hepatic Neoplasms

Keywords

Colorectal Neoplasms; Neoplasm Metastases; Magnetic Resonance Imaging; Diffusion Weighted MRI; Hepatic Neoplasms; Tumors; Neoplasms, Rectal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• 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)

• To describe the cancer specific disease free survival and overall survival outcomes in patients with and without 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.

  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.

  5 years after last recruit (end of trial)

Study Arms (1)

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.

Other: Diffusion Weighted MRI scan

Interventions

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.

Diffusion Weighted MRI scan

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a high risk primary colorectal malignancy
• Have a negative CT or includes no confirmatory evidence of liver metastases
• Is able to undergo treatment if liver metastasis is found
• Have provided written informed consent to participate in the study
• Be aged 16 years or over

You may not qualify if:

• Have had a previous colorectal malignancy
• Have metastatic disease
• Have a synchronous second malignancy
• Are contraindicated for MRI
• Has a T3b or below low rectal tumour without EMVI or N1c

Sponsors & Collaborators

• Imperial College London: lead
• Pelican Cancer Foundation: collaborator

Study Sites (13)

Macclesfield District General Hospital

Macclesfield, Cheshire, SK10 3BL, United Kingdom

RECRUITING

Queen's Hospital

Burton-on-Trent, Derbyshire, DE13 0RB, United Kingdom

NOT YET RECRUITING

Broomfield Hospital

Chelmsford, Essex, CM1 7ET, United Kingdom

RECRUITING

Royal Bolton Hospital

Bolton, Greater Manchester, BL4 0JR, United Kingdom

RECRUITING

Medway Maritime Hospital

Gillingham, Kent, ME7 5NY, United Kingdom

RECRUITING

University Hospital of South Manchester & Manchester Royal Infirmary

Wythenshawe, Manchester, M23 9LT, United Kingdom

RECRUITING

Royal Liverpool Hospital

Liverpool, Merseyside, L7 8XP, United Kingdom

RECRUITING

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

RECRUITING

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

Royal Gwent Hospital

Newport, Wales, NP20 2UB, United Kingdom

RECRUITING

George Eliot Hospital

Nuneaton, Warwickshire, CV10 7DJ, United Kingdom

RECRUITING

Salisbury District Hospital

Salisbury, Wiltshire, SP2 8BJ, United Kingdom

RECRUITING

Queen Alexandra Hospital

Portsmouth, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Liver Neoplasms; Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases

Study Officials

• Gina Brown

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 23, 2014
• Study Start: August 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

GB (13)