Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

FDG-PET/CT versus conventional CT for response monitoring in metastatic breast cancer: A pilot study for a randomized clinical trial (MONITOR-PILOT)

This pilot study, called MONITOR-PILOT, is for people living with breast cancer that has spread. Doctors want to see if a special type of scan called FDG-PET/CT is better than the usual CT scan for checking how well treatments are working. The main goal is to find out if using this new scan helps people live longer. They will also look at how it affects quality of life, how much treatment people need, and if it's a good use of healthcare money. The study will also track any side effects. Both men and women aged 18 and over can take part. This is an early study that will help plan a bigger trial in the future.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Odense University Hospital

Enrolment target

Start

25 Mar 2024

Metastatic breast cancer

What is this study about?

This study, called MONITOR-PILOT, is for people who have breast cancer that has spread to other parts of their body, also known as metastatic breast cancer. When breast cancer spreads, it can be more challenging to treat, and doctors are always looking for better ways to understand how well treatments are working for each person.

Currently, doctors often use regular CT (Computed Tomography) scans to check on the cancer and see if treatments are shrinking it or stopping it from growing. This study is testing a different type of scan called FDG-PET/CT. This scan can sometimes show how active cancer cells are, which might give doctors even more information than a standard CT scan about how your body is responding to treatment. The researchers want to find out if using this FDG-PET/CT scan instead of, or alongside, the usual CT scan can help doctors make better decisions about treatment, which could ultimately help people live longer.

Beyond just looking at how long people live, the study also aims to understand other important things. They will check if the new scan helps improve a person's quality of life – meaning how they feel day-to-day. They will also look at whether it reduces the amount of treatment someone needs, and if it's good value for the NHS. As with all treatments and tests, they will also carefully track any unexpected problems or side effects that might happen during the study.

Key takeaways

This study compares two types of scans (standard CT vs. FDG-PET/CT) for monitoring advanced breast cancer.
The main goal is to see if one scan method helps people live longer.
It also looks at quality of life, treatment duration, and cost-effectiveness.
Both men and women, aged 18 and over, with metastatic breast cancer can join.
Participation involves scan appointments and health checks, without changing your cancer treatment.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. The study is open to both men and women.

The most important thing is that you have breast cancer that has spread to other parts of your body (metastatic breast cancer). More detailed checks will be done by the study team to make sure it's safe and suitable for you to take part, as specific health details are important for these types of studies.

Your doctors will carefully review your medical history and current health to ensure that participating in this study is the best option for you. They will explain everything clearly if you are interested.

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?
Do you have breast cancer that has spread to other parts of your body (metastatic breast cancer)?
Are you able to attend scan appointments and follow the study schedule?
Are you comfortable with the possibility of having a PET/CT scan with a small amount of radioactive substance?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to either receive the usual CT scans or the special FDG-PET/CT scans to monitor your breast cancer. You'll continue with your regular breast cancer treatments as planned by your medical team. The study will mainly involve attending appointments for these scans and having regular check-ups where doctors will ask about your health and how you are feeling, including questions about your quality of life.

There might be additional blood tests or assessments compared to your usual care, but the researchers will ensure these are kept to a minimum. The total duration of your participation will depend on your treatment plan and how doctors need to monitor your cancer, but you will be told this clearly at the start. You'll have regular contact with the study team to support you throughout.

Potential risks and benefits

Taking part in any medical study carries both potential benefits and risks. A potential benefit of this study is that the FDG-PET/CT scan *might* provide more detailed information about your cancer's response to treatment, potentially leading to better-tailored care. However, this is what the study is trying to find out, so there's no guarantee. There are some risks associated with the scans themselves, such as a small exposure to radiation, similar to other medical scans you might have already had. The 'Fludeoxyglucose (18F)' is a small amount of a radioactive substance used to make the PET scan work, which typically has no side effects. You will be closely monitored for any adverse events or problems throughout the study. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is FDG-PET/CT?

It's a special type of scan that combines a PET scan (which shows how active cells are) and a CT scan (which shows detailed pictures of your body). It uses a small amount of a safe, temporary radioactive sugar to highlight areas where cancer cells might be.

Why are you comparing it to a regular CT scan?

Doctors want to find out if the FDG-PET/CT scan gives better information than the standard CT scan about how well breast cancer treatments are working, and if this helps people live longer and have a better quality of life.

Will my breast cancer treatment change if I join this study?

No, your breast cancer treatment will continue as planned by your medical team. This study is about *how* your response to that treatment is monitored, not about changing the treatment itself.

What does 'metastatic breast cancer' mean?

It means the breast cancer cells have spread from the breast to other parts of your body, such as the bones, liver, or lungs.

Can I stop participating in the study if I change my mind?

Yes, absolutely. Your participation is completely voluntary, and you can withdraw from the study at any time without giving a reason, and it will not affect your medical care.