Phase II study of [68Ga]Ga-ABY-025 PET for non-invasive quantification of HER2-status in solid tumors.
Some stomach, gullet, and breast cancers have a protein on their cells called HER2. Finding out how much HER2 is present helps doctors choose the most effective targeted medicines. At present, checking HER2 levels requires taking a small sample of tumour tissue using a needle (a biopsy). Biopsies can be uncomfortable and only show what is happening in one small area. This Phase II clinical trial is testing a new whole-body scan that uses a special tracking dye alongside a PET/CT scanner. Doctors hope this scan can detect and measure HER2 levels across the entire body painlessly and accurately. The study is for adults with stomach or gullet cancer that has HER2, as well as adults with advanced breast cancer that has low levels of HER2. If successful, this new scan could help doctors plan better, personalised treatments without needing repeated biopsies.
At a glance
What is this study about?
HER2 is a protein found on the surface of some cancer cells. When tumours have HER2, doctors can use specialised medicines that specifically target and attack these cells. Because of this, knowing whether a tumour has HER2—and how much of it is there—is an essential step in planning the best cancer treatment.
Currently, doctors find out if a cancer is HER2-positive by carrying out a biopsy, which involves taking a small piece of tissue with a needle or during surgery. While biopsies are very useful, they can cause soreness and carry minor risks like bleeding or infection. More importantly, cancer that has spread to different organs might not have the same amount of HER2 everywhere. A single biopsy only shows what is happening in one spot.
This trial is looking at a new imaging test that uses a tracer called 68Ga-ABY-025. This tracer is injected into a vein and travels through the bloodstream, sticking specifically to HER2 proteins on cancer cells. A PET/CT scanner then takes detailed pictures of the whole body, lighting up areas where HER2 is present.
Researchers will compare the scan results directly with standard biopsy results to see how reliable the scan is. They will also look at whether HER2 levels change after patients receive standard cancer treatments. If this scan works well, it could give doctors a clearer, gentler way to track cancer and choose treatments in the future.
Key takeaways
- This trial is testing a new whole-body scan to detect the HER2 protein in tumours.
- It is open to adults with stomach, gullet, or HER2-low breast cancer.
- The goal is to check cancer spread without needing repeated needle biopsies.
- The scan uses a specialised injection and takes less than an hour.
- Participation is voluntary and works alongside your normal NHS cancer treatment.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with specific types of solid tumours. It is split into two separate groups based on the type of cancer.
The first group is for people with cancer of the stomach or gullet (gastro-oesophageal cancer) that has tested positive for the HER2 protein. The second group is for people with advanced or secondary breast cancer that has low levels of HER2, often referred to by doctors as 'HER2-low' breast cancer.
Because the study compares scan images to laboratory tests, you will usually need to have had a standard biopsy or have one planned as part of your normal care. Your hospital care team can check your health records and scan history to confirm whether you meet all the safety rules to join.
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.
- You are aged 18 or older.
- You have been diagnosed with stomach cancer, gullet cancer, or breast cancer.
- Your tumour is known to have HER2 (for stomach/gullet cancer) or is 'HER2-low' (for breast cancer).
- You are comfortable lying flat and still inside an imaging scanner for about 45 minutes.
- You are able to travel to the trial hospital for the scanning appointment.
What does participation involve?
Taking part in this study takes place alongside your standard cancer care. During a study visit, a member of the healthcare team will place a small needle into a vein in your arm to give you an injection of the imaging tracer. You will then rest comfortably for a short time while the tracer moves around your body.
Next, you will lie flat on a padded bed that slowly slides through a PET/CT scanner. The scan is painless and usually takes around 30 to 45 minutes. For some patients with stomach or gullet cancer, a second scan may be arranged after you complete three cycles of your regular cancer treatment to see if the HER2 levels have changed. The trial team will check on your wellbeing, monitor any side effects, and review your regular hospital scans. Taking part does not replace your standard treatments.
Potential risks and benefits
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Common questions
Is the PET/CT scan painful?
No, the scan itself is completely painless. You will only feel a quick pinch when the small needle is placed in your vein for the injection.
Will taking part delay my normal cancer treatment?
No. The study scans are planned carefully around your normal treatment schedule so that your standard care is not interrupted.
Is the radioactive tracer harmful to me or my family?
The tracer uses a very small, carefully controlled amount of radiation. It breaks down quickly and leaves your body naturally in your urine within a day or two.
Will this scan replace the need for a biopsy right now?
Not during this trial. Researchers need to compare the scan pictures directly with standard biopsy results to prove that the scan works accurately.
Does it cost anything to take part?
No, taking part in the trial is free, and you will not have to pay for the study scans or hospital visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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