Novel PET imaging for HER2 in breast cancer
HERPET: A Mechanistic Non-Invasive Imaging Study of HER2 Expression in Breast Cancer Using [18F]GE-226 Positron Emission Tomography
This study is testing a new imaging agent to see if it can better target HER2 in patients with metastatic breast cancer and help doctors understand how it works in different types of tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Imperial College London Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (London) |
| Trial ID | NCT03827317 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the imaging agent [18F]GE-226 in targeting HER2 expression in patients with metastatic breast cancer. It will assess the uptake of [18F]GE-226 in tumor lesions and normal tissues, comparing results between HER2 positive and negative patients. The study will also determine the optimal timing for imaging and investigate the safety and metabolism of the agent. Additionally, it will explore potential biomarkers related to [18F]GE-226 uptake.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older with histologically confirmed metastatic breast cancer and known HER2 status.
Not a fit: Patients with early-stage breast cancer or those without a confirmed HER2 status may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of imaging HER2 expression in breast cancer, leading to better-targeted therapies.
How similar studies have performed: Other studies have shown promise in using PET imaging for cancer targeting, but this specific approach with [18F]GE-226 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female patients with a histological diagnosis of breast cancer with known HER2 status ((8 positive and 8 negative). 2. Written informed consent prior to admission in the study. 3. Target lesion diameter of ≥15mm that has not been previously irradiated. 4. Female patients aged ≥ 18 years of age. 5. For all patients: histologically confirmed locally advanced/metastatic breast cancer with a biopsy within the last 12 months confirming HER2 status by either immunohistochemistry (IHC), Silver In Situ Hybridization (SISH) or Fluorescent In Situ Hybridization (FISH). 6. ECOG performance status 0-2 7. Negative urine pregnancy test (within 2 hours prior to injection of imaging agent) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of \[18F\]GE-226 8. Life expectancy \> 3 months 9. Adequate organ function as defined by * Hb≥10g/L * WBC≥3.0 x 109/L * PLT≥80 x 109/L * Serum creatinine ≤1.4mg/dl * SGOT and SGPT ≤2 x ULN * Total bilirubin ≤ 2 x ULN or 3.0 mg/dl in patients with Gilbert's syndrome 10. Patients must have been appropriately staged using FDG-PET within 42 days of study entry and additional imaging according to local standard of care Exclusion Criteria: 1. Pregnant or lactating women. 2. History of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis). 3. Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial. 4. Participants with severe claustrophobia or who are unable to lie flat or fit into the scanner (≥350 lbs (160 Kg)). 5. Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent. 6. Patients classified as radiation workers 7. Patients on therapeutic doses of anticoagulants, or with a raised prothrombin time
Where this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Laura M Kenny, MD FRCP PhD — Imperial College London
- Study coordinator: HERPET Trial Coordinator
- Email: herpet@imperial.ac.uk; g.gopalakrishnan@imperial.ac.uk
- Phone: 0207 59 42804
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.