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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Evaluation of 68GaNOTA-Anti-HER2 VHH1 uptake in brain metastasis of cancer patients

This research is testing a new method to help doctors see if a specific protein, called HER2, is present in brain tumours that have spread from other types of cancer. The study uses a special tracing liquid, called 68Ga-NOTA-anti-HER2 VHH1. When this liquid is put into the body, it's designed to stick to HER2 proteins. Doctors will then take special scans to see if the tracing liquid lights up the brain tumours. This helps them understand whether this protein is a good target for treating these brain tumours. The goal is to see how clearly the tracing liquid shows up in these tumours and to compare it with how patients are doing over time. This is an early-stage study, meaning we are still exploring how this new method works.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Universitair Ziekenhuis Brussel
Enrolment target
30
Start
30 Jul 2024

What is this study about?

Imagine your body as having tiny building blocks called proteins. Sometimes, in certain cancers, a particular protein called HER2 can be found in larger amounts on the surface of cancer cells. When cancer spreads to the brain, it's really important for doctors to know if these brain tumours also have a lot of the HER2 protein because it can help guide treatment choices.

This study is trying out a new way to detect this HER2 protein in brain tumours. We're using a special tracing substance, called 68Ga-NOTA-anti-HER2 VHH1. Think of this substance as a 'tag' that's specifically designed to attach itself to HER2 proteins. When we put this tag into your body, it travels around. If there are HER2 proteins on the brain tumour cells, the tag should stick to them.

Once the tag has had time to find its way to the tumours, doctors will take special pictures, like a type of scan, to see where the tag has gathered. If the tag lights up brightly in the brain tumours, it means there are HER2 proteins there. This information is really important because it could help doctors understand more about these brain tumours and potentially lead to better ways to treat them in the future. We'll be carefully looking at these scans to see how well the tag works and if it gives us clear pictures.

Key takeaways

  • This study uses a new tracing liquid to detect a protein called HER2 in brain tumours.
  • It helps doctors learn more about how cancer cells in the brain behave.
  • The study involves receiving an injection of the tracing liquid and then having special scans.
  • It's an early-stage study, aiming to improve future diagnosis and treatment.
  • Participation is for adults aged 18 and over with cancer that has spread to the brain.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

The most important requirement is that you have been diagnosed with cancer that has spread to your brain. This study is specifically designed for people with these 'brain metastases'.

There might be other specific health requirements or conditions that would mean you can or cannot join the study, so it's always best to discuss it fully with your doctor.

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.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of cancer that has spread to your brain?
  3. Are you happy to undergo a special scan after an injection?
  4. Are you able to attend appointments at the study hospital?
  5. Are you comfortable with doctors studying your scan results?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be undergoing examinations related to the new tracing substance. This would involve receiving a small, safe amount of the tracing liquid, 68Ga-NOTA-anti-HER2 VHH1, which is given through a vein, much like a regular injection. After that, you would have special scans taken to see where the liquid has gone in your body, particularly in your brain.

During your time in the study, doctors will keep track of how your condition is progressing. If you are already receiving treatment, they might also compare the results of these scans before, during, and after your treatment to see if there are any changes. The total number of visits and the duration of your participation would be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and potential risks. A possible benefit of this study is that it might help researchers learn more about your specific type of brain tumour, which could lead to better treatments for you or others in the future. However, it's important to remember that this is an early-stage study, and we are still learning. As for risks, you might experience mild side effects from the tracing liquid or the scanning procedure, which the study team will discuss in detail with you. You are free to withdraw from the study at any time for any reason, without it affecting your medical care.

Locations (1)

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

Common questions

What is HER2 and why is it important?

HER2 is a protein that can be found in larger amounts on some cancer cells. Knowing if it's present can help doctors choose the best treatments.

What is 68Ga-NOTA-anti-HER2 VHH1?

It's a special tracing liquid that helps doctors see if the HER2 protein is present in your brain tumours using a scan.

Will this study cure my cancer?

No, this is an early-stage study focused on understanding how to better detect a specific protein. It's not a treatment study designed to cure cancer.

What kind of scans will I have?

You will have special scans after receiving the tracing liquid to see where it has gathered in your brain tumours.

Who is paying for this study?

The study's funding sources would be explained by the clinical trial team when you discuss participation.

How to find out more

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

Discussion

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