RecruitingNAINTERVENTIONAL

HERPET- A Novel PET Imaging Study of HER2 in Breast Cancer

This research is looking at a new imaging method for people with breast cancer that has spread. It uses a special, mildly radioactive tracer called [18F]GE-226 and a type of scan called a PET scan. The main goal is to see how well this tracer can pick up a protein called HER2, which is important in some breast cancers, and if it can tell the difference between HER2-positive and HER2-negative tumours. We also want to work out the best time to do the scan after giving the tracer, and to understand how safe it is for people. Ultimately, this could lead to better ways to understand and manage breast cancer.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

08 Mar 2019

Estimated completion

31 Dec 2026

Breast Cancer

What is this study about?

This study is exploring a new way to get a clear picture of breast cancer, especially cancer that has spread (metastatic breast cancer). We're focusing on a specific protein called HER2, which is found on the surface of some breast cancer cells and plays a role in how the cancer grows. Doctors can already test for HER2 in tissue samples, but this new method uses a special scanning technique called a PET scan with a unique tracer called [18F]GE-226. Think of the tracer as a tiny beacon that might attach specifically to HER2-positive cancer cells, allowing them to light up on the PET scan.

The main purpose of this research is to see how well this new tracer works. We want to find out if it can accurately show us where HER2 is in the body, and if it can tell the difference between cancers that have a lot of HER2 and those that don't. We'll also be trying to establish the best timing for doing the PET scan after the tracer is given, to get the clearest and most useful images. Understanding this could help doctors make more informed decisions about treatment in the future.

Another important aspect of the study is to check the safety of using this new tracer. We will carefully watch participants for any side effects and learn how the tracer behaves in the body. The hope is that this research will pave the way for a new, non-invasive tool that could provide valuable information about a patient's breast cancer, potentially guiding treatment choices and improving outcomes.

Key takeaways

Exploring a new PET scan method for breast cancer that has spread.
Aims to detect the HER2 protein more clearly using a special tracer.
Will assess the best timing for the scan and check the tracer's safety.
Could lead to better understanding and treatment guidance in the future.
Participation involves scans, blood tests, and careful health monitoring.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for women aged 18 or over who have breast cancer that has spread to other parts of the body (metastatic or locally advanced). Your doctors must have already determined the HER2 status of your cancer through a recent biopsy (in the last 12 months) – we need both HER2-positive and HER2-negative patients for comparison. You should also have at least one measurable tumour that hasn't been treated with radiation before.

There are some health requirements too. You'll need to be generally well enough to participate, with good organ function (blood, kidney, and liver tests) and a life expectancy of more than three months. You shouldn't be pregnant or breastfeeding. If you could become pregnant, you'll need to have a negative pregnancy test and agree to use contraception for three weeks after receiving the study tracer.

Certain conditions would prevent you from taking part, such as a history of heart problems, severe claustrophobia, or if you can't lie flat or fit into the scanner. You also shouldn't be taking certain blood thinners or other experimental medications. Anyone who is classified as a radiation worker is also not eligible for this study.

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 a woman aged 18 or over?
Do you have breast cancer that has spread (metastatic/locally advanced)?
Do you know your cancer's HER2 status from a recent biopsy?
Do you have at least one tumour that hasn't been radiated before?
Are you generally well, with good blood, kidney, and liver function?
Are you not pregnant or breastfeeding, and willing to use contraception if needed?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you will receive a small, safe amount of the special tracer, [18F]GE-226, which is mildly radioactive. You will then have several PET scans at different times after the tracer is given, which involves lying still in a scanner. We will also take blood and urine samples to check your general health, how the tracer moves through your body, and for any potential side effects.

Throughout the study, we will carefully monitor your health and well-being. This includes physical examinations, checking your vital signs (like blood pressure and heart rate), and performing ECGs (heart tracings). You'll be asked about any new symptoms or feelings you experience. The total duration of your participation will depend on the study schedule, but it typically involves a few visits to the hospital.

Potential risks and benefits

Participating in this study might offer the potential benefit of contributing to new medical knowledge that could help future breast cancer patients. You might also gain a deeper understanding of your own cancer through the advanced imaging, though this scan is for research purposes. Potential risks include those associated with exposure to a small amount of radiation from the tracer and PET scans, as well as possible side effects from the tracer injection, although serious reactions are expected to be rare. There's also the inconvenience of multiple hospital visits and tests. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is HER2 and why is it important?

HER2 is a protein on breast cancer cells. Finding out if a cancer has a lot of HER2 (HER2-positive) can help doctors choose the right treatments.

What is a PET scan?

A PET scan is a type of imaging test that uses a special, mildly radioactive 'tracer' to show how well your organs and tissues are working or if there are any changes in cells.

Is the tracer ([18F]GE-226) safe?

The tracer is given in very small, safe amounts, and its safety will be carefully monitored throughout the study. We expect serious side effects to be rare.

How much radiation will I be exposed to?

You will be exposed to a small amount of radiation, similar to other medical scans you might have. The research team will explain this fully.

Will this study help my cancer directly?

While the scan provides more information about your cancer, this is primarily a research study to understand the new imaging method. It might not directly change your current treatment, but it contributes to future cancer care.

How to find out more

HERPET Trial Coordinator

herpet@imperial.ac.uk; g.gopalakrishnan@imperial.ac.uk 0207 59 42804 Official trial record

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