Trial Title:
Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)
NCT ID:
NCT02246634
Condition:
Colorectal Neoplasms
Neoplasm Metastases
Hepatic Neoplasms
Conditions: Official terms:
Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Conditions: Keywords:
Colorectal Neoplasms
Neoplasm Metastases
Magnetic Resonance Imaging
Diffusion Weighted MRI
Hepatic Neoplasms
Tumors
Neoplasms, Rectal
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Diffusion Weighted MRI scan
Description:
Liver metastases found on the additional DW-MRI scans will be discussed at MDT and
treated according to local site policy.
Arm group label:
Diffusion Weighted MRI scan
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Macclesfield District General Hospital
Address:
City:
Macclesfield
Zip:
SK10 3BL
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Pippa Hill
Email:
philippahill@nhs.net
Contact backup:
Last name:
Lesley Wilkinson
Email:
lesley.wilkinson8@nhs.net
Investigator:
Last name:
Chris Smart
Email:
Principal Investigator
Facility:
Name:
Queen's Hospital
Address:
City:
Burton upon Trent
Zip:
DE13 0RB
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Helena Cox
Email:
Helena.Cox@burtonft.nhs.uk
Investigator:
Last name:
Manjusha Keni
Email:
Principal Investigator
Facility:
Name:
Broomfield Hospital
Address:
City:
Chelmsford
Zip:
CM1 7ET
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Lauren Shillito
Email:
lauren.shillito@meht.nhs.uk
Investigator:
Last name:
Peng Lee
Email:
Principal Investigator
Facility:
Name:
Royal Bolton Hospital
Address:
City:
Bolton
Zip:
BL4 0JR
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Raksha Mistry
Email:
Raksha.mistry@boltonft.nhs.uk
Investigator:
Last name:
Gemma Faulkner
Email:
Principal Investigator
Facility:
Name:
Medway Maritime Hospital
Address:
City:
Gillingham
Zip:
ME7 5NY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Suzie Rayner
Email:
Suzie.Reyner@medway.nhs.uk
Investigator:
Last name:
Iheoma Amaechi
Email:
Principal Investigator
Facility:
Name:
University Hospital of South Manchester & Manchester Royal Infirmary
Address:
City:
Wythenshawe
Zip:
M23 9LT
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Lindsay Piper
Email:
Lindsay.Piper@UHSM.NHS.UK
Investigator:
Last name:
Sarah Duff
Email:
Principal Investigator
Facility:
Name:
Royal Liverpool Hospital
Address:
City:
Liverpool
Zip:
L7 8XP
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Matthew Noonan
Email:
Matthew.Noonan@rlbuht.nhs.uk
Investigator:
Last name:
Catriona Farrell
Email:
Principal Investigator
Facility:
Name:
Royal Stoke University Hospital
Address:
City:
Stoke-on-Trent
Zip:
ST4 6QG
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Julie Storer
Phone:
01782 672557
Email:
Julie.storer@uhnm.nhs.uk
Contact backup:
Last name:
Michelle Swann
Phone:
01782 675859
Email:
Michelle.Swann@uhnm.nhs.uk
Investigator:
Last name:
Ravivarma Balasubramaniam
Email:
Principal Investigator
Facility:
Name:
Royal Marsden Hospital
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Cordelia Grant
Email:
cordelia.grant@rmh.nhs.uk
Investigator:
Last name:
Christos Kontovounisios
Email:
Principal Investigator
Facility:
Name:
Royal Gwent Hospital
Address:
City:
Newport
Zip:
NP20 2UB
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Heeam Nassa
Email:
Heeam.Nassa@wales.nhs.uk
Investigator:
Last name:
Mark Robinson
Email:
Principal Investigator
Facility:
Name:
George Eliot Hospital
Address:
City:
Nuneaton
Zip:
CV10 7DJ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Pritpal Klear
Email:
Pritpal.Klear@geh.nhs.uk
Contact backup:
Last name:
Holly Lawrence
Email:
Holly.Lawrence@geh.nhs.uk
Investigator:
Last name:
Jamal Abdulkarim
Email:
Principal Investigator
Facility:
Name:
Salisbury District Hospital
Address:
City:
Salisbury
Zip:
SP2 8BJ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Ruth Casey
Email:
Ruth.Casey@salisbury.nhs.uk
Investigator:
Last name:
Graham Branagan
Email:
Principal Investigator
Facility:
Name:
Queen Alexandra Hospital
Address:
City:
Portsmouth
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Nicola Gibbons
Email:
nicola.gibbons@porthosp.nhs.uk
Investigator:
Last name:
Antony Higginson
Email:
Principal Investigator
Start date:
August 2014
Completion date:
December 2031
Lead sponsor:
Agency:
Imperial College London
Agency class:
Other
Collaborator:
Agency:
Pelican Cancer Foundation
Agency class:
Other
Source:
Imperial College London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02246634
