72
Participants
Start Date
November 23, 2022
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
[68Ga]Ga-ABY-025 PET
\[68Ga\]Ga-ABY-025 PET: Each patient in Cohort 1 will be imaged with a PET/CT twice using the radiolabeled investigational product ABY-025 as a tracer. At the time of injection, a 45-minutes long dynamic scan will take place over a pre specified region of interest. Three hours after injection a full body PET scan followed by a CT scan will be performed.
Biopsy and analysis of HER2 expression
Biopsy: Within 3 days after the first ABY-025-PET a tissue sample from at least one metastasis \>10 mm available for biopsy, preferably shallow lymph nodes, will be analyzed for HER2 expression through immunohistochemistry- (IHC) and in situ hybridization- (ISH) analysis in patients with GEAC and HER2low mBC.
RECRUITING
Department of Radiation Physics and Nuclear Medicine, Karolinska University Hospital, Stockholm
Karolinska University Hospital
OTHER