Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
19
Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT
Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY86-7548 in blood
Unnamed facility
Turku, Finland
Unnamed facility
Ulm, Baden-Wurttemberg, Germany
Unnamed facility
Zurich, Canton of Zurich, Switzerland
Visual assessment of lesions
Time frame: Day of study drug administration
Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)
Time frame: Day of study drug administration
ECG (significant abnormalities)
Time frame: At least 3 times until one day after treatment
Blood pressure
Time frame: At least 3 times until one day after treatment
Serum protein
Time frame: At least 3 times until one day after treatment
Serum creatinine
Time frame: At least 3 times until one day after treatment
Serum GOT (Glutamat-Oxalacetat-Transaminase)
Time frame: At least 3 times until one day after treatment
Adverse events collection
Time frame: Continuously for at least 5 days after treatment
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