Breast Cancer Clinical Trial
Official title:
68Ga-NOTA-AE105. Evaluation of a New Radiotracer Targeting uPAR (Urokinase Plasminogen Activator Receptor), for Positron Emission Tomography Imaging of the Invasive Cancer Phenotype. First in Human
The primary objective of the study is to test a new radiotracer called 68Ga-NOTA-AE105 for PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and less aggressive tumors. This is a first in human study to test the radiotracer in cancer patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).
The primary objective of the study is to test a new radiotracer called 68Ga-NOTA-AE105 for PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and less aggressive tumors. This is a first in human study to test the radiotracer in cancer patients. The biodistribution and tumor uptake will be evaluated by repeated PET scans (10 minutes, 1 and 2 hours post injection). The primary end points are safety, biodistribution and dosimetry of 68Ga-NOTA-AE105. In addition, the quantitative uptake of 68Ga-NOTA-AE105 will be compared to the expression of uPAR measured directly in tumor tissue obtained by surgery or biopsies. The project will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP). ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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