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Clinical Trial · NCT00756691
A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA
Overview
Hypoxia (little of no oxygen) is considered to be an important characteristic of a patient's tumour that may help predict patient outcomes and/or help inform patient management decisions. 18F-FAZA Positron Emission Tomography (PET) can detect hypoxic tumours because 18F-FAZA accumulates in hypoxic tissues. This study is being done to learn more about the processes by which 18F-FAZA is absorbed, distributed, metabolized (built-up and broken down) and eliminated by the body.
Sponsor
AHS Cancer Control Alberta
Contacts
Alexander McEwan, MB, FRCPC (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT00756691Drug / Compound
FAZA
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):
- Hypoxia
Ligand Class: Small Molecules
Eligibility
Inclusion
- Able and willing to follow instructions and comply with the protocol
- Karnofsky Performance Scale Score of 70-100
- Subjects with known primary or suspected metastatic SCC head and neck; NSCLC; SCLC; GBM; lymphoma, or NET with at least one lesion \> 1 cm in diameter
Exclusion
- Bilirubin \> or = to 200 umol/L
- Previous treatment for their primary or metastatic SCC head and neck, NSCLC, SCLC, GBM, Lymphoma, or NET
- Serious medical conditions such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections, uncontrolled diabetes
- Nursing or pregnant females
- Creatinine \> or - to 150 umol/L
- AST or ALT \> or = to 5 times the upper limits of normal
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