Novel PET imaging for HER2 in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.