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Brief Title: HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025
Official Title: Phase 1 Study, Evaluating HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025
Study ID: NCT02095210
Brief Summary: This is an open-labeled, exploratory, single center study. Patients with a big primary breast cancer (≥ 3 cm) or metastatic first line, routinely have their HER2-expression determined by biopsy. Patients having a HER2-positive tumor will be recruited to the study. A \[18F\]FDG PET/ceCT scan is performed for the measurement of uptake in the tumour and diagnosis of possible metastases. Each subject will receive a single injection of the investigational product \[68Ga\]ABY-025, followed by measurement of uptake in the tumour or metastases and in normal organs. The investigations will be repeated after HER2 directed therapy.
Detailed Description: see above
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Herlev University Hospital, Oncology Department, Herlev, , Denmark
Name: Malgorzata K Tuxen, MD, P.hd.
Affiliation: Consultant
Role: PRINCIPAL_INVESTIGATOR