This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
Cancer patients, injection of BAY 85-8050, PET/CT
Healthy volunteers, injection of BAY 85-8050, whole body PET/CT for determination of effective dose, kinetics of BAY 85-8050 in blood
Unnamed facility
München, Bavaria, Germany
Visual assessment of lesions
Time frame: Within up to 2 hours after treatment
Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs)
Time frame: Within up to 2 hours after treatment
Serum chemistry:Glutamate pyruvate transaminase (GPT/ALAT), gamma-glutamyl transferase (gamma-GT), glutamate-oxaloacetate transaminase (GOT), alkaline phosphatase, total bilirubin, creatinine, total protein
Time frame: At least 2 times within 8 days after treatment
Electrocardiogram (ECG)
Time frame: at least 2 times within 8 days after treatment
Vital signs: Heart rate, blood pressure
Time frame: at least 2 times within 8 days after treatment
Adverse events collection
Time frame: continuously for at least 8 days after treatment
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