Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-03-05 @ 10:47 AM
Study NCT ID:
NCT02246634
Status:
RECRUITING
Last Update Posted:
2024-10-17
First Post:
2014-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)
Sponsor:
Imperial College London
Organization:
Study Overview
Official Title:
Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI.
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SERENADE
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: