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

NCT ID: NCT02246634

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Neoplasms Neoplasm Metastases Hepatic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diffusion Weighted MRI scan

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

Group Type EXPERIMENTAL

Diffusion Weighted MRI scan

Intervention Type OTHER

Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.

Interventions

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Diffusion Weighted MRI scan

Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pelican Cancer Foundation

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gina Brown

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Macclesfield District General Hospital

Macclesfield, Cheshire, United Kingdom

Site Status RECRUITING

Queen's Hospital

Burton-on-Trent, Derbyshire, United Kingdom

Site Status NOT_YET_RECRUITING

Broomfield Hospital

Chelmsford, Essex, United Kingdom

Site Status RECRUITING

Royal Bolton Hospital

Bolton, Greater Manchester, United Kingdom

Site Status RECRUITING

Medway Maritime Hospital

Gillingham, Kent, United Kingdom

Site Status RECRUITING

University Hospital of South Manchester & Manchester Royal Infirmary

Wythenshawe, Manchester, United Kingdom

Site Status RECRUITING

Royal Liverpool Hospital

Liverpool, Merseyside, United Kingdom

Site Status RECRUITING

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, United Kingdom

Site Status RECRUITING

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

Site Status RECRUITING

Royal Gwent Hospital

Newport, Wales, United Kingdom

Site Status RECRUITING

George Eliot Hospital

Nuneaton, Warwickshire, United Kingdom

Site Status RECRUITING

Salisbury District Hospital

Salisbury, Wiltshire, United Kingdom

Site Status RECRUITING

Queen Alexandra Hospital

Portsmouth, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Caroline Martin

Role: CONTACT

+44 (0) 7749 655 817

Syvella Ellis

Role: CONTACT

+44 (0) 7732 315 234

Facility Contacts

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Pippa Hill

Role: primary

Lesley Wilkinson

Role: backup

Helena Cox

Role: primary

Lauren Shillito

Role: primary

Raksha Mistry

Role: primary

Suzie Rayner

Role: primary

Lindsay Piper

Role: primary

Matthew Noonan

Role: primary

Julie Storer

Role: primary

01782 672557

Michelle Swann

Role: backup

01782 675859

Cordelia Grant

Role: primary

Heeam Nassa

Role: primary

Pritpal Klear

Role: primary

Holly Lawrence

Role: backup

Ruth Casey

Role: primary

Nicola Gibbons

Role: primary

Other Identifiers

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DOCUMAS: 17HH4153

Identifier Type: -

Identifier Source: org_study_id

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