RecruitingNAINTERVENTIONAL

FDG-PET/CT vs. CT for Monitoring Metastatic Breast Cancer

This research trial, called MONITOR-RCT, is looking into the best way to monitor advanced breast cancer. It compares the usual imaging method, called a CT scan, with a more detailed scan called an FDG-PET/CT. The researchers want to find out if using FDG-PET/CT helps doctors spot changes in the cancer earlier, which might mean starting new treatments sooner. They hope this could help people with advanced breast cancer live longer and enjoy a better quality of life. The study involves 420 patients across Denmark, Germany, and Italy, who have recently been diagnosed with advanced breast cancer and are starting their first treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Odense University Hospital

Enrolment target

420

Start

02 Apr 2025

Estimated completion

01 Apr 2029

Metastatic Breast Cancer Response Monitoring

What is this study about?

This study is for people who have advanced breast cancer, meaning it has spread to other parts of the body (metastatic breast cancer). When someone has advanced breast cancer, doctors need to regularly check how well the treatment is working. This helps them decide if the current treatment needs to change.

Currently, there isn't one best way to monitor treatment, but standard CT scans are often used. However, some newer evidence suggests a different type of scan, called an FDG-PET/CT, might be better at finding small changes in the cancer earlier. This trial aims to prove if FDG-PET/CT can improve how long patients live and their overall wellbeing.

The MONITOR-RCT trial will compare these two scanning methods directly. Half of the patients will have their treatment monitored with standard CT scans, and the other half will use FDG-PET/CT scans. By comparing these groups, doctors hope to understand if using FDG-PET/CT helps patients by allowing for quicker changes in treatment if needed, potentially leading to better outcomes and a better quality of life.

Key takeaways

Compares two scan types (CT vs. FDG-PET/CT) for monitoring advanced breast cancer.
Aims to see if FDG-PET/CT helps patients live longer and have better quality of life.
Participation involves regular scans and filling out questionnaires.
You will receive standard cancer treatments throughout the study.
The study helps doctors understand the best ways to monitor cancer treatment.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have a recent diagnosis of breast cancer that has spread to other parts of your body (metastatic breast cancer). This diagnosis usually needs to be confirmed by a biopsy (a small tissue sample). You should also be starting your first round of treatment for this type of breast cancer and be well enough to have regular scans to check on your condition.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you are currently being treated for another type of cancer. Also, if your breast cancer has only spread to your brain, or if you have an allergy to the dye used in an FDG-PET/CT scan, you would not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been diagnosed with breast cancer that has spread (metastatic)?
Are you about to start your first treatment for metastatic breast cancer?
Are you able to have regular scans to check on your condition?
Are you *not* pregnant or breastfeeding, and not currently being treated for another cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be in one of two groups. One group will have regular FDG-PET/CT scans to monitor their cancer, while the other group will have regular CT scans, which is the standard way of monitoring. You will receive your usual cancer treatments as decided by your doctors, and the results of your scans will help guide these treatments.

Throughout the study, you will also be asked to fill out questionnaires. These questionnaires will ask about your quality of life – how you are feeling and how the treatments are affecting your daily life. This helps the researchers understand the bigger picture of how different monitoring methods might impact patients. The study aims to follow participants over a period to see the long-term effects of each monitoring approach.

Potential risks and benefits

Taking part in this study may offer potential benefits in allowing closer monitoring of your cancer, which could help your doctors adjust your treatment more effectively. The imaging scans involve some radiation exposure, which is a small risk. However, the study procedures are carefully planned to minimise risks. You will always receive care based on current best practices, regardless of which monitoring group you are in. It's important to remember that you are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Aalborg University Hospital
Verified postcode
Aalborg, Denmark· Recruiting
Aarhus University Hospital
Verified postcode
Aarhus, Denmark· Recruiting
Rigshospitalet
Verified postcode
Copenhagen, Denmark· Recruiting
Esbjerg and Grindsted Hospital
Verified postcode
Esbjerg, Denmark· Recruiting
Herlev and Gentofte Hospital
Verified postcode
Herlev, Denmark· Recruiting
Odense University Hospital
Verified postcode
Odense, Denmark· Recruiting
Hospital of Southern Jutland
Verified postcode
Sønderborg, Denmark· Recruiting
Lille Baelt Hospital
Verified postcode
Vejle, Denmark· Recruiting
Klinikum Der Technischen Universität München
Verified postcode
München, Germany· Not yet recruiting
Irccs Azienda Ospedaliero - Universitario Di Bologna
Verified postcode
Bologna, Italy· Recruiting
Humanitas Research Hospital
Verified postcode
Milan, Italy· Not yet recruiting

Common questions

What is 'metastatic breast cancer'?

This means breast cancer has spread from the breast to other parts of the body, like bones or lungs.

What's the difference between a CT scan and an FDG-PET/CT scan?

A CT scan takes detailed X-ray pictures inside your body. An FDG-PET/CT scan is more advanced; it uses a special dye to show areas where cancer cells are active, which can help detect changes earlier.

Will I still get my usual cancer treatments?

Yes, you will receive standard cancer treatments as prescribed by your doctors. This study is about *how* your treatment response is monitored, not about the specific treatments themselves.

Why is 'quality of life' important in this study?

Researchers want to see if better monitoring not only helps people live longer but also improves their everyday life and how they feel during treatment. You'll complete questionnaires to share your experiences.

How long will I be in the study?

The study will follow participants over a period to understand the long-term effects of the monitoring methods. Specific durations will be discussed with you by the study team.

How to find out more

Malene G Hildebrandt, MD, Professor

malene.grubbe.hildebrandt@rsyd.dk 0045 30171888 Official trial record

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