At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- [18F]GE-226 (radiation)
- How long the study runs
- Study runs about 93 months (dates as stated)
- About the drug or intervention
- [18F]GE-226 — radiation: \[18F\]GE-226 is a radiolabelled Affibody® tracer which binds to the HER2 receptor with high affinity at a different epitope than trastuzumab.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Imperial College London, is testing a new type of PET (positron emission tomography) scan that images HER2, a protein found on some breast cancer cells. Researchers want to see whether the scan can detect HER2 in the body. The study plans to include 8 women with HER2-positive breast cancer and 8 with HER2-negative breast cancer.
Who can take part
- Women aged 18 or over with a confirmed diagnosis of locally advanced or metastatic breast cancer (cancer that has spread)
- HER2 status checked by a tissue biopsy within the last 12 months
- A tumour measuring at least 15mm that has not previously been treated with radiotherapy
- Able to carry out day-to-day activities at least some of the time (performance status 0-2)
- Life expectancy of more than 3 months
- Healthy enough blood, liver and kidney test results
- A pregnancy test (if of child-bearing age) showing negative within 2 hours before the scan injection, and willingness to use contraception (barrier method, abstinence, or non-hormonal) for 3 weeks after the injection
- Written informed consent to take part
- Already had an FDG-PET scan and other standard imaging before joining the study
Who may not be able to
- Women who are pregnant or breastfeeding
- A history of heart problems such as heart attack, arrhythmia (irregular heartbeat) needing treatment, valve disease, cardiomyopathy, or pericarditis
- Severe claustrophobia, being unable to lie flat, or weighing 160kg (350lbs) or more
- Taking another experimental drug, or having taken one within 14 days before joining
- Being a radiation worker
- Taking therapeutic doses of blood-thinning medicine (anticoagulants) or having a raised prothrombin time
- Any other significant medical condition or test result that, in the researcher's opinion, makes taking part unsafe or unsuitable
What taking part involves
- • Receiving an injection of a radioactive imaging substance called [18F]GE-226
- • Having a PET scan to see if it can pick up HER2 in the body
Time commitment: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 24
- Started
- 2019-03-08
- Last checked
- 2024-08
Plain English Summary
What is this study?
- • Testing a new treatment for breast cancer
- • NA - 24 participants
- • This mechanistic study will be the first study to assess the efficacy of \[18F\]GE-226 to target HER2 expression in patients with metastatic breast cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast cancer
- • Female only
Where?
- • London - Imperial College Healthcare NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This mechanistic study will be the first study to assess the efficacy of \[18F\]GE-226 to target HER2 expression in patients with metastatic breast cancer. The study will establish the pharmacokinetics of \[18F\]GE-226 and the optimum time-point for performing static scans in this patient population.
More detail
Objectives Primary: * To determine the uptake in tumour lesions and normal tissue of \[18F\]GE-226 and compare the difference between patients with HER2 positive and HER2 negative lesions. Uptake will be quantified by semi-quantitative (SUV, AUC) and fully quantitative parameters (Ki in the case of irreversible uptake, and binding potential in the case of reversible uptake) * To determine the optimal imaging time point for \[18F\]GE-226 Secondary: * To determine the safety and toxicity of \[18F\]GE-226 PET in humans * To determine if \[18F\]GE-226 can distinguish between HER2 amplified and HER2 non-amplified breast tumours * To determine the metabolism of \[18F\]GE-226 in human subjects Exploratory: • To explore circulating biomarkers that may be related to \[18F\]GE-226 uptake and to investigate if treatment modulates \[18F\]GE-226 Endpoints Secondary: * Safety and toxicity of \[18F\]GE-226 measured by adverse events from administration of \[18F\]GE-226 injection throughout the study period, and clinically significant changes from baseline measurements in serum biochemistry, haematology, coagulation, immunology, urinalysis, vital signs, ECG, injection site and physical examination findings. * The association between \[18F\]GE-226 tumour uptake and standard HER2 pathological testing (HER2 amplified and HER2 non-amplified breast tumours) * Proportion of metabolised \[18F\]GE-226 at scheduled time-points compared to baseline * Normal tissue uptake of \[18F\]GE-226 will be quantified in the appropriate regions depending on the field of view. Exploratory: • To perform preliminary biodistribution analysis, to compare \[18F\]GE- 226 uptake to \[18F\]FDG uptake in tumour lesion
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
What the study is looking for
- ✓Female patients with a histological diagnosis of breast cancer with known HER2 status ((8 positive and 8 negative).
- ✓Written agreement to take part prior to admission in the study.
- ✓Target lesion diameter of ≥15mm that has not been previously irradiated.
- ✓Female patients aged ≥ 18 years of age.
- ✓ECOG performance status 0-2
Who cannot take part
- ✗Pregnant or lactating women.
- ✗History of heart disease (myocardial infarction, arrhythmias requiring therapy, causing symptoms valvular disease,...
- ✗Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it...
- ✗Participants with severe claustrophobia or who are unable to lie flat or fit into the scanner (≥350 lbs (160 Kg)).
- ✗Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent.
See the full criteria
Where Is This Study? (1 UK site)
Imperial College Healthcare NHS Trust
London W12 0NN, United Kingdom
How to Get in Touch
HERPET Trial Coordinator
Sponsor contactCONTACT
Gosala Gopalakrishnan, PhD
Sponsor contactCONTACT