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Clinical Trial · NCT02805608
uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
Overview
The sensitivity and specificity of uPAR PET/CT with the radioligand 68GaNOTA-AE105 and FDG PET/MRI for preoperative detection of regional lymph node metastases in urinary bladder cancer
Phase
Phase 2
Contacts
Dorthe Skovgaard, Md, PhD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT02805608Drug / Compound
FDG
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Glucose Transport
Ligand Class: Small Molecules
AE105
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- uPAR
Ligand Class: Peptides
Chelator: NOTA
Eligibility
Inclusion
- Biopsy-verified urinary bladder cancer
Exclusion
- Treatment with neoadjuvant chemotherapy
- Pregnancy
- Known allergy towards 68Ga-NOTA-AE105
- Weight above 140 kg
- Lactation/breast feeding
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