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

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ClinicalTrials.gov Identifier: NCT02246634
Recruitment Status : Unknown
Verified March 2017 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : September 23, 2014
Last Update Posted : February 26, 2018
Sponsor:
Collaborator:
Pelican Cancer Foundation
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:

Patients diagnosed with colorectal cancer routinely undergo a CT scan to identify whether the cancer has spread to other parts of the body, but diagnosis of secondary cancer in the liver is difficult using conventional CT. MRI is known to be better than CT at diagnosing cancer in the liver but it takes a long time to do. Recently it has been suggested that limited MRI of the liver can identify most cancer in the liver, however this has not yet been proven to be effective in patients with a new diagnosis of colorectal cancer. The purpose of this study is to test whether a quick MRI scan of the liver at the time colorectal cancer is diagnosed can identify more cancer that has spread to the liver than conventional CT.

All patients who have been diagnosed with a high risk type of colorectal cancer but no liver metastases on CT will be eligible to take part in the study.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Neoplasm Metastases Hepatic Neoplasms Other: Diffusion Weighted MRI scan Not Applicable

Detailed Description:

Everyone who agrees to take part will have a short specialist MRI scan, called diffusion weighted MRI, to look for cancer in the liver. Normally you will have this scan within 4 weeks of joining the study. You will be able to start your cancer treatment while you are in the study so having this scan will not delay the start of your treatment. If the diffusion weighted MRI scan of the liver is abnormal you will asked to return for another MRI scan of your liver, this time with an injection of contrast during the scan, to establish whether you have cancer in the liver. If this scan is positive for cancer your doctors will discuss with you the best method of treating your colorectal cancer and the cancer in your liver, which may include additional chemotherapy, radiotherapy or another operation.

We also want to find out about your quality of life; therefore we will ask you to fill out a short questionnaire at one year and at two years after you join the study.

All participants will be followed up by their doctors, as per standard. There are no follow up visits specifically for the study although we will carefully monitor your progress for three years.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI.
Study Start Date : August 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diffusion Weighted MRI scan
Patients in the study will get a DW-MRI of the liver in addition to their standard treatment imaging prior to their surgery.
Other: Diffusion Weighted MRI scan
Non-contrast diffusion weighted MRI scan of the liver




Primary Outcome Measures :
  1. To measure a >5% increase in the incidence of synchronous liver metastases additionally diagnosed by DW-MRI when CT is negative or does not confirm the presence of metastatic disease. [ Time Frame: 5 years after last recruit ]

Secondary Outcome Measures :
  1. To measure the quality of life and patient reported outcome measures using EORTC QLQ - CR29 questionnaire, collected at one year after registration. [ Time Frame: 1 year after last recruit ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246634


Contacts
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Contact: Gina Brown +442086613964 gina.brown@rmh.nhs.uk
Contact: Lisa Scerri +442089156067 lisa.scerri@gmail.com

Locations
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United Kingdom
Macclesfield District General Hospital Recruiting
Macclesfield, Cheshire, United Kingdom, SK10 3BL
Contact: Pippa Hill       philippahill@nhs.net   
Contact: Lesley Wilkinson       lesley.wilkinson8@nhs.net   
Principal Investigator: Chris Smart         
Queen's Hospital Not yet recruiting
Burton upon Trent, Derbyshire, United Kingdom, DE13 0RB
Contact: Helena Cox       Helena.Cox@burtonft.nhs.uk   
Principal Investigator: Manjusha Keni         
Broomfield Hospital Recruiting
Chelmsford, Essex, United Kingdom, CM1 7ET
Contact: Lauren Shillito       lauren.shillito@meht.nhs.uk   
Principal Investigator: Peng Lee         
Royal Bolton Hospital Recruiting
Bolton, Greater Manchester, United Kingdom, BL4 0JR
Contact: Raksha Mistry       Raksha.mistry@boltonft.nhs.uk   
Principal Investigator: Gemma Faulkner         
Medway Maritime Hospital Recruiting
Gillingham, Kent, United Kingdom, ME7 5NY
Contact: Suzie Rayner       Suzie.Reyner@medway.nhs.uk   
Principal Investigator: Iheoma Amaechi         
University Hospital of South Manchester & Manchester Royal Infirmary Recruiting
Wythenshawe, Manchester, United Kingdom, M23 9LT
Contact: Lindsay Piper       Lindsay.Piper@UHSM.NHS.UK   
Principal Investigator: Sarah Duff         
Royal Liverpool Hospital Recruiting
Liverpool, Merseyside, United Kingdom, L7 8XP
Contact: Matthew Noonan       Matthew.Noonan@rlbuht.nhs.uk   
Principal Investigator: Catriona Farrell         
Royal Stoke University Hospital Recruiting
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Contact: Julie Storer    01782 672557    Julie.storer@uhnm.nhs.uk   
Contact: Michelle Swann    01782 675859    Michelle.Swann@uhnm.nhs.uk   
Principal Investigator: Ravivarma Balasubramaniam         
Royal Marsden Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Lisa Scerri       lisa.scerri@nhs.net   
Principal Investigator: Gina Brown         
Royal Gwent Hospital Recruiting
Newport, Wales, United Kingdom, NP20 2UB
Contact: Heeam Nassa       Heeam.Nassa@wales.nhs.uk   
Principal Investigator: Mark Robinson         
George Eliot Hospital Recruiting
Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
Contact: Pritpal Klear       Pritpal.Klear@geh.nhs.uk   
Contact: Holly Lawrence       Holly.Lawrence@geh.nhs.uk   
Principal Investigator: Jamal Abdulkarim         
Salisbury District Hospital Recruiting
Salisbury, Wiltshire, United Kingdom, SP2 8BJ
Contact: Ruth Casey       Ruth.Casey@salisbury.nhs.uk   
Principal Investigator: Graham Branagan         
Queen Alexandra Hospital Recruiting
Portsmouth, United Kingdom
Contact: Nicola Gibbons       nicola.gibbons@porthosp.nhs.uk   
Principal Investigator: Antony Higginson         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Pelican Cancer Foundation
Investigators
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Principal Investigator: Gina Brown Royal Marsden Hospital Foundation Trust

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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02246634     History of Changes
Other Study ID Numbers: CCR 4156
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: March 2017
Keywords provided by Royal Marsden NHS Foundation Trust:
Colorectal Neoplasms
Neoplasm Metastases
Magnetic Resonance Imaging
Diffusion Weighted MRI
Hepatic Neoplasms
Tumors
Neoplasms, Rectal
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplasms
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
Liver Diseases