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Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)
Conditions
Colorectal Neoplasms - Neoplasm Metastases - Hepatic Neoplasms
Conditions: official terms
Colorectal Neoplasms - Liver Neoplasms - Neoplasm Metastasis - Neoplasms
Conditions: Keywords
Colorectal Neoplasms, Neoplasm Metastases, Magnetic Resonance Imaging, Diffusion Weighted MRI, Hepatic Neoplasms, Tumors, Neoplasms, Rectal
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Diffusion Weighted MRI scan
Type: Other
Overall Status
Recruiting
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.
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
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.
Location
Royal Marsden Hospital NHS Foundation Trust
London/Surrey, United Kingdom
Status: Recruiting
Contact: Lisa Scerri - +442089156067 - lisa.scerri@rmh.nhs.uk
Start Date
August 2014
Completion Date
August 2019
Sponsors
Royal Marsden NHS Foundation Trust
Source
Royal Marsden NHS Foundation Trust
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page