RecruitingNAINTERVENTIONAL

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

The SERENADE study is investigating a new way to detect if bowel cancer has spread to the liver. It focuses on patients who have a type of bowel cancer that doctors consider high-risk, meaning there's a greater chance it might spread. Currently, these patients would have a CT scan, and this study is for those whose CT scan doesn't show any cancer in the liver. Researchers want to see if adding special MRI scans, called diffusion-weighted MRIs (DW-MRI), can find any hidden spread to the liver earlier than CT scans alone. Finding cancer spread earlier could help doctors make treatment decisions more quickly. If liver spread is found, doctors will discuss it and decide on the best treatment plan according to usual hospital procedures. Participants will have these extra MRI scans every six months for three years after their surgery.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

282

Start

01 Aug 2014

Estimated completion

01 Dec 2031

Colorectal Neoplasms Neoplasm Metastases Hepatic Neoplasms

What is this study about?

The SERENADE study is looking into a new way to find if bowel cancer has spread to the liver. Bowel cancer can sometimes spread to other parts of the body, and the liver is a common place for this to happen. When cancer spreads, it's called 'metastases'. This study is specifically for people who have been diagnosed with a type of bowel cancer called 'high-risk colorectal cancer'. This means doctors believe there's a higher chance of the cancer spreading, even if it hasn't been seen yet on initial scans.

Currently, after bowel cancer surgery, patients usually have scans to check for any spread. This study wants to see if adding a special type of MRI scan, called a diffusion-weighted MRI (DW-MRI), can help doctors find any hidden cancer spread in the liver earlier than regular CT scans alone. The DW-MRI is a very detailed scan that can show changes in tissues that might not be obvious on other scans.

Finding any spread to the liver as early as possible is very important. If doctors can spot it sooner, it might help them decide on the best treatment plan for you more quickly. This study will compare how well the DW-MRI scans work alongside the usual CT scans in picking up these changes. All decisions about your treatment, including any liver cancer found, will still be made by your local team of doctors and specialists.

Key takeaways

The study uses special MRI scans to find hidden bowel cancer spread in the liver.
It's for people with 'high-risk' bowel cancer whose first scans show no liver spread.
Participation involves extra MRI scans every six months for three years.
Early detection could help doctors make quicker treatment decisions.
Your normal doctor care will continue, regardless of study participation.

Who may be eligible?

To join this study, you need to be at least 16 years old and have a type of bowel cancer that doctors consider 'high-risk'. This means your cancer has certain features that make it more likely to spread, such as being T3 or T4, having spread more than 5mm, or being EMVI positive.

It's important that your initial CT scan for your bowel cancer didn't show any signs of cancer in your liver. You also need to be well enough to have treatment if any liver cancer is found. Before joining, you'll need to read and sign a form to show you understand what the study involves.

There are also some reasons you wouldn't be able to join. For example, if you've had bowel cancer before, already have cancer that has spread to other parts of your body, or have another type of cancer at the same time. You also can't join if you can't have an MRI scan for medical reasons, or if your cancer is a specific type (T3b or below low rectal tumour without EMVI or N1c).

Quick self-check

Are you 16 years old or over?
Do you have a 'high-risk' type of bowel cancer?
Did your initial CT scan not show any cancer in your liver?
Are you able to have treatment if liver cancer is found?
Have you *not* had bowel cancer before?
Are you able to have an MRI scan?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, after your bowel cancer surgery, you will have additional MRI scans specifically of your liver. These MRI scans will be done every six months for a total of three years. These are called Diffusion Weighted MRI scans and do not involve injecting any dye (contrast) into your veins. The MRI scans will include different types of images (T1, T2, and DW-MRIs) to get a detailed look at your liver.

During these regular MRI appointments, you'll be asked to hold your breath for short periods while the scans are being taken. This helps to get clear pictures. You won't need to take any new medication for the study, and there aren't any extra clinic visits beyond the MRI appointments. The information from your MRI scans will be reviewed by doctors, and if anything is found, it will be discussed with your local hospital's team of specialists, who will then decide on any necessary steps for your care. The total duration of your active participation, involving these additional scans, will be three years.

Potential risks and benefits

Taking part in this study might help detect any spread of your bowel cancer to the liver earlier than usual. This early detection could allow your doctors to make quicker decisions about your treatment, potentially leading to better outcomes. The main risks involve the MRI scans themselves, which are generally very safe but can be noisy and make some people feel slightly anxious. There's also the chance that the scans might show something that leads to more investigations or treatments. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (13)

Macclesfield District General Hospital
Macclesfield, United Kingdom· Recruiting
Queen's Hospital
Burton-on-Trent, United Kingdom· Not yet recruiting
Broomfield Hospital
Chelmsford, United Kingdom· Recruiting
Royal Bolton Hospital
Bolton, United Kingdom· Recruiting
Medway Maritime Hospital
Gillingham, United Kingdom· Recruiting
University Hospital of South Manchester & Manchester Royal Infirmary
Wythenshawe, United Kingdom· Recruiting
Royal Liverpool Hospital
Liverpool, United Kingdom· Recruiting
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom· Recruiting
Royal Marsden Hospital
Sutton, United Kingdom· Recruiting
Royal Gwent Hospital
Newport, United Kingdom· Recruiting
George Eliot Hospital
Nuneaton, United Kingdom· Recruiting
Salisbury District Hospital
Salisbury, United Kingdom· Recruiting

+1 more sites — see the official record for the full list.

Common questions

What is a DW-MRI?

A DW-MRI is a special type of MRI scan that is very good at showing tiny changes in body tissues, which could help doctors spot cancer spread that might not be visible on other scans.

Will I have to pay to be part of this study?

No, you will not have to pay to participate in this study. All scans and participation in the study are provided free of charge.

What happens if they find something on my MRI scan?

If the MRI scan shows something unusual in your liver, your local team of doctors will discuss it and decide on the best next steps for your care, following their usual hospital procedures.

Will I still have my regular scans?

Yes, you will still receive all your usual and necessary scans and follow-up care as recommended by your doctors, in addition to the extra MRI scans for this study.

Is an MRI scan painful?

No, an MRI scan is not painful. You lie still in a tunnel-like scanner, and it can be noisy, but it doesn't hurt. You might be given headphones to help with the noise.

How to find out more

Caroline Martin

c.martin1@imperial.ac.uk +44 (0) 7749 655 817 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.