HERPET- A Novel PET Imaging Study of HER2 in Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT03827317
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Female patients with a histological diagnosis of breast cancer with known HER2<br> status ((8 positive and 8 negative).<br><br> 2. Written informed consent prior to admission in the study.<br><br> 3. Target lesion diameter of =15mm that has not been previously irradiated.<br><br> 4. Female patients aged = 18 years of age.<br><br> 5. For all patients: histologically confirmed locally advanced/metastatic breast cancer<br> with a biopsy within the last 12 months confirming HER2 status by either<br> immunohistochemistry (IHC), Silver In Situ Hybridization (SISH) or Fluorescent In<br> Situ Hybridization (FISH).<br><br> 6. ECOG performance status 0-2<br><br> 7. Negative urine pregnancy test (within 2 hours prior to injection of imaging agent)<br> in women of child bearing age and willingness to use contraception (barrier,<br> abstinence, non-hormonal) for 3 weeks after injection of [18F]GE-226<br><br> 8. Life expectancy > 3 months<br><br> 9. Adequate organ function as defined by<br><br> - Hb=10g/L<br><br> - WBC=3.0 x 109/L<br><br> - PLT=80 x 109/L<br><br> - Serum creatinine =1.4mg/dl<br><br> - SGOT and SGPT =2 x ULN<br><br> - Total bilirubin = 2 x ULN or 3.0 mg/dl in patients with Gilbert's syndrome<br><br> 10. Patients must have been appropriately staged using FDG-PET within 42 days of study<br> entry and additional imaging according to local standard of care<br><br>Exclusion Criteria:<br><br> 1. Pregnant or lactating women.<br><br> 2. History of cardiac disease (myocardial infarction, arrhythmias requiring therapy,<br> symptomatic valvular disease, cardiomyopathy, or pericarditis).<br><br> 3. Evidence of significant medical condition or laboratory finding which, in the<br> opinion of the Investigator, makes it undesirable for the patient to participate in<br> the trial.<br><br> 4. Participants with severe claustrophobia or who are unable to lie flat or fit into<br> the scanner (=350 lbs (160 Kg)).<br><br> 5. Prior use within 14 days of enrolment or concurrent therapy with any other<br> investigational agent.<br><br> 6. Patients classified as radiation workers<br><br> 7. Patients on therapeutic doses of anticoagulants, or with a raised prothrombin time
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 breast cancer measured using fully quantitative parameters
- Secondary Outcome Measures
Name Time Method Adverse events of [18F]GE-226 injection;Serum biochemistry change from baseline measurement;Haematology change from baseline measurement;Immunology change from baseline measurement;Urine change from baseline measurement;EEG change from baseline measurement