Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Study to assess the safety and potential use of GEH121224 (18F) Injection to visualise HER2-Receptor expression using PET imaging in patients with Metastatic Breast Cancer

This study is for women with breast cancer that has spread to other parts of the body. Doctors are testing a new type of injection called GEH121224 (18F). This injection is given just before a special scan called a PET scan. The aim is to see if the injection helps doctors clearly see a specific feature on cancer cells, called a HER2-Receptor. Knowing if these HER2-Receptors are present can help doctors decide on the best way to treat the cancer. The study is in its early stages (Phase I and II), which means researchers are checking how safe it is and if it works as they hope.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

GE Healthcare Limited

Enrolment target

Start

01 Oct 2024

Metastatic breast cancer

What is this study about?

This research study is about finding better ways to understand and treat breast cancer that has spread to different parts of the body, also known as metastatic breast cancer. When breast cancer spreads, it can be more challenging to treat, so doctors are always looking for new methods to help them make the best treatment choices for each person.

The main idea behind this study is to use a special injection called GEH121224 (18F) along with a type of scan called a PET scan. The injection contains a tiny amount of a substance that is designed to stick to something specific on breast cancer cells called HER2-Receptors. Not all breast cancers have HER2-Receptors, but if they do, certain treatments work well against them. The PET scan then helps doctors see where these HER2-Receptors are located in the body, which can give them valuable information about your cancer.

By carefully looking at the results from this new injection and scan, doctors hope to get a clearer picture of your specific cancer. This information could then help them choose the most effective treatments for you. This is an early-stage study (Phase I and Phase II), which means the researchers are mainly checking if the new injection is safe and if it can successfully help them see these HER2-Receptors.

Key takeaways

This study is for women with breast cancer that has spread.
It uses a new injection and a PET scan to find HER2-Receptors on cancer cells.
The goal is to help doctors understand the cancer better for treatment planning.
It's an early-stage study checking safety and if the method works.
Participation involves hospital visits, an injection, and scans.

Who may be eligible?

This study is looking for women who are at least 18 years old and have breast cancer that has spread to other parts of their body (metastatic breast cancer).

If you are a man, or if your breast cancer has not spread, this study would not be the right fit for you. Also, if you are under 18, you won't be able to join this particular research.

The research team will carry out several checks to make sure this study is safe and suitable for you. These checks are important to ensure your wellbeing throughout the trial.

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?
Are you a woman?
Do you have breast cancer that has spread to other parts of your body?
Are you generally well enough to attend hospital visits and scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several visits to the hospital or clinic. These visits will involve various tests to check your health, such as blood tests and physical examinations. You will receive the study injection, GEH121224 (18F), which is given into a vein. Shortly after the injection, you will have a PET scan. The study team will explain everything to you in detail.

The exact number and timing of visits, and any follow-up appointments, will be explained by the study team. They will also tell you how long your involvement in the study is expected to last, from your first visit to your final check-up.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that it might help doctors learn more about your specific cancer, which could eventually lead to better treatment choices. However, there's no guarantee that participating will directly benefit your health. As with any injection, there's a small risk of discomfort or bruising. PET scans involve a very small amount of radiation, which the doctors will discuss with you. It's important to remember that you are free to leave 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
Sweden

Common questions

What is metastatic breast cancer?

Metastatic breast cancer is breast cancer that has spread from the breast to other parts of the body, such as the bones, liver, or lungs.

What is a PET scan?

A PET scan is a special type of imaging test that uses a small amount of a radioactive substance to look for disease in the body. It can show how organs and tissues are working.

What is a HER2-Receptor?

HER2 is a protein found on the surface of some breast cancer cells. If cancer cells have a lot of HER2, it's called HER2-positive, and there are specific treatments that can target it.

Is GEH121224 (18F) a new treatment?

No, GEH121224 (18F) is an injection used as part of a scan to find HER2-Receptors, not a treatment itself. The study tests if it can help doctors see these receptors better.

Can I get this injection outside of the study?

No, because this is a research study in its early stages, the GEH121224 (18F) injection is only available to participants in this specific trial.