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

Sponsor

Royal Marsden NHS Foundation Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT02246634

Collaborator

Pelican Cancer Foundation (Other)

282

Enrollment

Locations

Arm

Duration (Months)

21.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

282 participants

Allocation:

N/A

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 :

Aug 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2019

Anticipated Study Completion Date :

Aug 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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. [5 years after last recruit]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Macclesfield District General Hospital	Macclesfield	Cheshire	United Kingdom	SK10 3BL
2	Queen's Hospital	Burton upon Trent	Derbyshire	United Kingdom	DE13 0RB
3	Broomfield Hospital	Chelmsford	Essex	United Kingdom	CM1 7ET
4	Royal Bolton Hospital	Bolton	Greater Manchester	United Kingdom	BL4 0JR
5	Medway Maritime Hospital	Gillingham	Kent	United Kingdom	ME7 5NY
6	University Hospital of South Manchester & Manchester Royal Infirmary	Wythenshawe	Manchester	United Kingdom	M23 9LT
7	Royal Liverpool Hospital	Liverpool	Merseyside	United Kingdom	L7 8XP
8	Royal Stoke University Hospital	Stoke-on-Trent	Staffordshire	United Kingdom	ST4 6QG
9	Royal Marsden Hospital	Sutton	Surrey	United Kingdom	SM2 5PT
10	Royal Gwent Hospital	Newport	Wales	United Kingdom	NP20 2UB
11	George Eliot Hospital	Nuneaton	Warwickshire	United Kingdom	CV10 7DJ
12	Salisbury District Hospital	Salisbury	Wiltshire	United Kingdom	SP2 8BJ
13	Queen Alexandra Hospital	Portsmouth		United Kingdom