Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-9596 in patients with cancer and inflammation
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
35
Healthy volunteers, single intravenous bolus injection of 200 MBq BAY 86-9596 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY 86-9596 in blood and urine
Cancer patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
Inflammation patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
Subgroup of cancer patients: radiation induced inflammation. Fluordeoxyglucose (18F)-FDG PET scan will be performed approx. 4 week after radiation and compared with tracer BAY86-9596 (acc. to Amendment 4 only in the Netherlands)
Unnamed facility
Groningen, Provincie Groningen, Netherlands
Unnamed facility
Zurich, Canton of Zurich, Switzerland
Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)
Time frame: Day of study drug administration
Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs)
Time frame: Day of study drug administration
Vital signs (ECG, blood pressure, Heart rate, Body temperature)
Time frame: At least 2 times within 8 days after treatment
Serum chemistry, Clotting status, Hematology
Time frame: At least 2 times within 8 days after treatment
Adverse Event collection
Time frame: At least 2 times within 8 days after treatment
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