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.

NCT02139371 EARLY_PHASE1 COMPLETED

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).

Details

Lead sponsor	Rigshospitalet, Denmark
Phase	EARLY_PHASE1
Status	COMPLETED
Enrolment	10
Start date	2014-05
Completion	2014-10

Conditions

• Breast Cancer
• Prostate Cancer
• Urinary Bladder Cancer

Interventions

• Injection of 64Cu-DOTA-AE105

Primary outcomes

• Biodistribution — 24 hours
  The patients will be PET scanned 1, 3 and 24 hours post injection of the radiotracer 64Cu-DOTA-AE105. These different timepoints will be used for assessment of biodistribution
• Dosimetry — 24 hours
  The patients will be PET scanned 1, 3 and 24 hours post injection of the radiotracer 64Cu-DOTA-AE105. These different timepoints will be used for calculation of dosimetry

Countries

Denmark