Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-4367 in patients with cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
16
Cancer patients, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, PET/CT
Healthy volunteers, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, whole body PET/CT for determination of effective dose., kinetics of BAY86-4367 in blood
Unnamed facility
München, Bavaria, Germany
Unnamed facility
Zurich, Canton of Zurich, Switzerland
Visual assessment of lesions
Time frame: Day of study drug administration
Quantitative analysis of BAY86-4367 uptake into lesions (Standardized Uptake Values = SUVs)
Time frame: Day of study drug administration
Electrocardiogram (ECG)
Time frame: At least 3 times within 8 days after treatment
Blood pressure
Time frame: At least 3 times within 8 days after treatment
Serum protein
Time frame: At least 3 times within 8 days after treatment
Serum creatinine
Time frame: At least 3 times within 8 days after treatment
Serum GOT (Glutamat-Oxalacetat-Transaminase)
Time frame: At least 3 times within 8 days after treatment
Adverse events collection
Time frame: At least 3 times within 8 days after treatment
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