HERPET- A Novel PET Imaging Study of HER2 in Breast Cancer
Recruiting · NCT03827317 · Interventional (participants receive a specific treatment) · Lead sponsor: Imperial College London
View the official record on ClinicalTrials.gov →Interventions studied
[18F]GE-226
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Female patients with a histological diagnosis of breast cancer with known HER2 status ((8 positive and 8 negative).
- Written informed consent prior to admission in the study.
- Target lesion diameter of ≥15mm that has not been previously irradiated.
- Female patients aged ≥ 18 years of age.
- 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).
- ECOG performance status 0-2
- 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
- Life expectancy \> 3 months
- 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
- 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
- Pregnant or lactating women.
- History of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis).
- 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.
- 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.
- Patients classified as radiation workers
- Patients on therapeutic doses of anticoagulants, or with a raised prothrombin time
Where it is running
1 location listed.
- Imperial College Healthcare NHS Trust - London, United Kingdom