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

ID: NCT02246634
Status: Recruiting
Phase: N/A
Start Date: August 01, 2014
First Submitted: September 05, 2014
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: Royal Marsden NHS Foundation Trust, Pelican Cancer Foundation
Location: United Kingdom
Conditions: Colorectal Neoplasms, Neoplasm Metastases, Hepatic Neoplasms
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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.

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.
Condition or disease Intervention/treatment Phase

Colorectal Neoplasms

Hepatic Neoplasms

Neoplasm Metastases

Other: Diffusion Weighted MRI scan
Other Names
N/A

Tracking Information

First Submitted DateSeptember 05, 2014
Last Update Posted DateFebruary 23, 2018
Start DateAugust 01, 2014
Anticipated Completion DateAugust 01, 2019
Primary Completion DateAugust 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current 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. [Time Frame: 5 years after last recruit]

Original Primary Outcome Measures

Not Available

Current 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. [Time Frame: 1 year after last recruit]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleScreening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)
Official TitleScreening for Synchronous Metastases in Colorectal Cancer With DW-MRI.
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.

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 TypeInterventional
Study PhaseN/A
Estimated Enrollment
282
Allocation
Not Available
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Diagnostic
Conditions
Colorectal Neoplasms
Hepatic Neoplasms
Neoplasm Metastases
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Other: Diffusion Weighted MRI scan

Non-contrast diffusion weighted MRI scan of the liver

Other Names
Study Groups/Cohorts
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.

Study Arms
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

Recruitment Information

Recruitment Status:Recruiting
Enrollment282
Completion DateAugust 01, 2019
Eligibility 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United Kingdom

Administrative Information

NCT Number:NCT02246634
Other Study ID Numbers
CCR 4156
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Pelican Cancer Foundation
Investigators
Principal Investigator
Gina Brown
Royal Marsden Hospital Foundation Trust