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Brief Title: Evaluation of a New Radiotracer (64Cu-DOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography
Official Title: 64Cu-DOTA-AE105. Evaluation of a New Radiotracer Targeting uPAR (Urokinase Plasminogen Activator Receptor) for Positron Emission Tomography Imaging of the Invasive Cancer Phenotype. First in Man.
Study ID: NCT02139371
Brief Summary: The primary objective of the study is to test a new radiotracer called 64Cu-DOTA-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 (1,3 and 24 hours post injection).
Detailed Description: The primary objective of the study is to test a new radiotracer called 64Cu-DOTA-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 (1,3 and 24 hours post injection). The primary end points are Biodistribution and dosimetry of 64Cu-DOTA-AE105. In addition, the quantitative uptake of 64Cu-DOTA-AE105 in tumors and expression of uPAR in tumor tissue obtained by surgery or biopsies (either 14 days before (only biopsies) or after the PET scans) will be compared to validate the image-derived data on UPAR expression
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen, , Denmark
Name: Dorthe Skovgaard, MD, Phd
Affiliation: Rigshospitalet, Denmark
Role: PRINCIPAL_INVESTIGATOR