Breast Cancer Clinical Trial
Official title:
HERPET: A Mechanistic Non-Invasive Imaging Study of HER2 Expression in Breast Cancer Using [18F]GE-226 Positron Emission Tomography
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College Healthcare NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | Medical Research Council, University of Cambridge |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumoral uptake of [18F]GE-226 in patients with breast cancer measured using semi-quantitative parameters | Tumoral uptake of [18F]GE-226 in patients with HER2 positive and HER2 negative breast cancer measured using SUV and AUC. | 24 months | |
Primary | Tumoral uptake of [18F]GE-226 in patients with breast cancer measured using fully quantitative parameters | Tumoral uptake of [18F]GE-226 in patients with HER2 positive and HER2 negative breast cancer measured using Ki in the case or irreversible uptake, and binding potential in the case of reversible uptake. | 24 months | |
Secondary | Adverse events of [18F]GE-226 injection | Safety of [18F]GE-226 measured by adverse events from administration of [18F]GE-226 injection throughout the study period. | 0 hour, 48 hours | |
Secondary | Serum biochemistry change from baseline measurement | Safety of [18F]GE-226 injection measured by clinically significant changes from baseline measurements in serum biochemistry finding. | 0 hour, 48 hours | |
Secondary | Haematology change from baseline measurement | Safety of [18F]GE-226 injection measured by haematology change from baseline measurements. | 0 hour, 48 hours | |
Secondary | Immunology change from baseline measurement | Safety of [18F]GE-226 injection measured by clinically significant changes from baseline measurements in immunology | 0 hour, 48 hours | |
Secondary | Urine change from baseline measurement | Safety of [18F]GE-226 injection measured by clinically significant changes from baseline measurements in urine | 0 hour, 48 hours | |
Secondary | EEG change from baseline measurement | Safety of [18F]GE-226 injection measured by clinically significant changes from baseline measurements in ECG | 0 hour, 48 hours |
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