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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Diffusion Weighted MRI scan (other)
How long the study runs: Study runs about 208 months (dates as stated)
About the drug or intervention: Diffusion Weighted MRI scan — other: Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.
Patient visit burden: Not specified by the sponsor

In plain English

This study, run by Imperial College London, is looking at a special type of MRI scan (diffusion-weighted magnetic resonance imaging, or DW-MRI) to find cancer spread (metastases) in people with a new bowel (colorectal) cancer, including spread to the liver. The researchers want to see whether this scan can help find cancer spread that a CT scan may have missed.

Who can take part

You have a newly found primary bowel cancer that is high risk
Your CT scan was negative or did not clearly show cancer spread to the liver
You are able to have treatment if liver spread is found
You have given written informed consent to take part
You are aged 16 or over

Who may not be able to

You have had bowel cancer before
You already have cancer that has spread
You have a second cancer at the same time
You cannot have an MRI scan for health or safety reasons
You have a low rectal tumour staged T3b or below, without EMVI (cancer in blood vessels) or N1c (cancer deposits in nearby tissue)

What taking part involves

• Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 16 Years and over
Who: All
Number of participants: 282
Started: 2014-08
Last checked: 2024-10

Plain English Summary

What is this study?

• Testing a new treatment for colorectal neoplasms
• NA - 282 participants
• 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

Who can take part?

• Ages 16 Years and over
• Diagnosed with colorectal neoplasms

Where?

• Macclesfield - Macclesfield District General Hospital
• Burton-on-Trent - Queen's Hospital
• Chelmsford - Broomfield Hospital
• Bolton - Royal Bolton Hospital
• +9 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Colorectal NeoplasmsNeoplasm MetastasesHepatic Neoplasms

How this trial compares with your answers

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What we know so far

Condition· Matched your search

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 16 Years and over
Who can join: All genders

Biomarkers mentioned

Have a negative

What the study is looking for

✓Have a high risk primary colorectal cancer
✓Have a negative CT or includes no confirmatory evidence of liver metastases
✓Is able to undergo treatment if liver metastasis is found
✓Have provided written agreement to take part to participate in the study
✓Be aged 16 years or over

Who cannot take part

✗Have had a previous colorectal cancer
✗Have that has spread disease
✗Have a synchronous second cancer
✗Are not safe to use for MRI
✗Has a T3b or below low rectal tumour without EMVI or N1c

See the full criteria

Inclusion Criteria: 1. Have a high risk primary colorectal malignancy 2. Have a negative CT or includes no confirmatory evidence of liver metastases 3. Is able to undergo treatment if liver metastasis is found 4. Have provided written informed consent to participate in the study 5. Be aged 16 years or over Exclusion Criteria: 1. Have had a previous colorectal malignancy 2. Have metastatic disease 3. Have a synchronous second malignancy 4. Are contraindicated for MRI 5. Has a T3b or below low rectal tumour without EMVI or N1c