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Clinical Trial · NCT02139371
Evaluation of a New Radiotracer (64Cu-DOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography
Overview
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).
Phase
Early Phase 1
Contacts
Dorthe Skovgaard, MD, Phd (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT02139371Drug / Compound
AE105
Isotope(s):
COPPER-64
Radioisotope: Cu-64
Theranostic Role: PET Imaging
T1/2 (Half-Life): 12.7 Hours
Decay Mode: POSITRON β+, BETA, Electron Capture, GAMMA
Energy: 0.65 MeV, Gamma 511 keV
Range: max 2.5mm, mean 0.7mm
Decay Daughters: Ni64 (Stable), Zn64 (Stable)
Status: FDA Approval: DETECTNET®
Target(s):
- uPAR
Ligand Class: Peptides
Chelator: DOTA
Eligibility
Inclusion
- clinical diagnosis of cancer of prostate, breast or urinary bladder
Exclusion
- pregnancy
- contraindication for the use of intravenous CT contrast-agencies
- claustrophobia
- lactation
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