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

Primary Purpose

Colorectal Neoplasms, Neoplasm Metastases, Hepatic Neoplasms

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Diffusion Weighted MRI scan

About this trial

This is an interventional diagnostic trial for Colorectal Neoplasms focused on measuring Colorectal Neoplasms, Neoplasm Metastases, Magnetic Resonance Imaging, Diffusion Weighted MRI, Hepatic Neoplasms, Tumors, Neoplasms, Rectal

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

High risk primary colorectal cancer (as determined by CT or MRI).
CT which is negative or no confirmatory evidence of metastatic disease .
Patient aged over 18 years

Exclusion Criteria:

Patients who are unable to give consent, who withhold consent or who withdraw consent will be excluded.
Patient is undergoing active treatment or follow-up for another malignancy (excluding basal cell carcinoma).
Patient has a contraindication to CT or MRI (e.g. intraocular metal fragments, pacemaker, severe claustrophobia)
Patients who are pregnant or breast feeding.
Patients who have received systemic treatment for colorectal cancer.
Patients with any metastatic disease.

Sites / Locations

Macclesfield District General HospitalRecruiting
Queen's Hospital
Broomfield HospitalRecruiting
Royal Bolton HospitalRecruiting
Medway Maritime HospitalRecruiting
University Hospital of South Manchester & Manchester Royal InfirmaryRecruiting
Royal Liverpool HospitalRecruiting
Royal Stoke University HospitalRecruiting
Royal Marsden HospitalRecruiting
Royal Gwent HospitalRecruiting
George Eliot HospitalRecruiting
Salisbury District HospitalRecruiting
Queen Alexandra HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diffusion Weighted MRI scan

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

To determine the sensitivity and specificity of DW-MRI as a screening method for liver lesions in patients with high risk colorectal cancer.

% 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.

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.

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.

Proportion of patients undergoing curative treatment and methods of treatment

Full Information

NCT ID

NCT02246634

First Posted

September 5, 2014

Last Updated

August 21, 2023

Sponsor

Imperial College London

Collaborators

Pelican Cancer Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02246634

Brief Title

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

Acronym

SERENADE

Official Title

Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 2014 (undefined)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imperial College London

Collaborators

Pelican Cancer Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms, Neoplasm Metastases, Hepatic Neoplasms

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

282 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diffusion Weighted MRI scan

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Diffusion Weighted MRI scan

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Proportion of additional patients diagnosed with liver metastases on DW MRI compared with CT.

Time Frame

5 years after last recruit (end of trial)

Secondary Outcome Measure Information:

Title

To compare the baseline risk factors of the primary tumour against the timing and pattern of metastatic disease relapse in the liver.

Description

% of patients diagnosed with liver metastases according to known prognostic risk factors

Time Frame

5 years after last recruit (end of trial)

Title

To determine the sensitivity and specificity of DW-MRI as a screening method for liver lesions in patients with high risk colorectal cancer.

Description

% 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.

Time Frame

5 years after last recruit (end of trial)

Title

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

Description

Survival and recurrence outcomes according to presence or absence of liver metastases

Time Frame

6mth, 12mth, 18mth, 2yr, 3yr

Title

To characterise the patients diagnosed through screening with liver metastasis in the SERENADE study using the Fong criteria.

Description

Fong score of all patients with liver metastases

Time Frame

5 years after last recruit (end of trial)

Title

To describe the impact of MR screening on treatment received by patients who are diagnosed with liver metastases.

Description

Proportion of patients undergoing curative treatment and methods of treatment

Time Frame

5 years after last recruit (end of trial)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Caroline Martin

Phone

+44 (0) 7749 655 817

c.martin1@imperial.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Syvella Ellis

Phone

+44 (0) 7732 315 234

giclinicaltrials@imperial.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gina Brown

Organizational Affiliation

Imperial College London

Official's Role

Principal Investigator

Facility Information:

Facility Name

Macclesfield District General Hospital

City

Macclesfield

State/Province

Cheshire

ZIP/Postal Code

SK10 3BL

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pippa Hill

philippahill@nhs.net

First Name & Middle Initial & Last Name & Degree

Lesley Wilkinson

lesley.wilkinson8@nhs.net

First Name & Middle Initial & Last Name & Degree

Chris Smart

Facility Name

Queen's Hospital

City

Burton upon Trent

State/Province

Derbyshire

ZIP/Postal Code

DE13 0RB

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Helena Cox

Helena.Cox@burtonft.nhs.uk

First Name & Middle Initial & Last Name & Degree

Manjusha Keni

Facility Name

Broomfield Hospital

City

Chelmsford

State/Province

Essex

ZIP/Postal Code

CM1 7ET

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lauren Shillito

lauren.shillito@meht.nhs.uk

First Name & Middle Initial & Last Name & Degree

Peng Lee

Facility Name

Royal Bolton Hospital

City

Bolton

State/Province

Greater Manchester

ZIP/Postal Code

BL4 0JR

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raksha Mistry

Raksha.mistry@boltonft.nhs.uk

First Name & Middle Initial & Last Name & Degree

Gemma Faulkner

Facility Name

Medway Maritime Hospital

City

Gillingham

State/Province

Kent

ZIP/Postal Code

ME7 5NY

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suzie Rayner

Suzie.Reyner@medway.nhs.uk

First Name & Middle Initial & Last Name & Degree

Iheoma Amaechi

Facility Name

University Hospital of South Manchester & Manchester Royal Infirmary

City

Wythenshawe

State/Province

Manchester

ZIP/Postal Code

M23 9LT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lindsay Piper

Lindsay.Piper@UHSM.NHS.UK

First Name & Middle Initial & Last Name & Degree

Sarah Duff

Facility Name

Royal Liverpool Hospital

City

Liverpool

State/Province

Merseyside

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthew Noonan

Matthew.Noonan@rlbuht.nhs.uk

First Name & Middle Initial & Last Name & Degree

Catriona Farrell

Facility Name

Royal Stoke University Hospital

City

Stoke-on-Trent

State/Province

Staffordshire

ZIP/Postal Code

ST4 6QG

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julie Storer

Phone

01782 672557

Julie.storer@uhnm.nhs.uk

First Name & Middle Initial & Last Name & Degree

Michelle Swann

Phone

01782 675859

Michelle.Swann@uhnm.nhs.uk

First Name & Middle Initial & Last Name & Degree

Ravivarma Balasubramaniam

Facility Name

Royal Marsden Hospital

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cordelia Grant

cordelia.grant@rmh.nhs.uk

First Name & Middle Initial & Last Name & Degree

Christos Kontovounisios

Facility Name

Royal Gwent Hospital

City

Newport

State/Province

Wales

ZIP/Postal Code

NP20 2UB

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heeam Nassa

Heeam.Nassa@wales.nhs.uk

First Name & Middle Initial & Last Name & Degree

Mark Robinson

Facility Name

George Eliot Hospital

City

Nuneaton

State/Province

Warwickshire

ZIP/Postal Code

CV10 7DJ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pritpal Klear

Pritpal.Klear@geh.nhs.uk

First Name & Middle Initial & Last Name & Degree

Holly Lawrence

Holly.Lawrence@geh.nhs.uk

First Name & Middle Initial & Last Name & Degree

Jamal Abdulkarim

Facility Name

Salisbury District Hospital

City

Salisbury

State/Province

Wiltshire

ZIP/Postal Code

SP2 8BJ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ruth Casey

Ruth.Casey@salisbury.nhs.uk

First Name & Middle Initial & Last Name & Degree

Graham Branagan

Facility Name

Queen Alexandra Hospital

City

Portsmouth

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicola Gibbons

nicola.gibbons@porthosp.nhs.uk

First Name & Middle Initial & Last Name & Degree

Antony Higginson

12. IPD Sharing Statement

Learn more about this trial

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

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