Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY94-9392 in patients with cancer or inflammation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
46
Unnamed facility
Stanford, California, United States
Unnamed facility
München, Bavaria, Germany
Unnamed facility
Seoul, South Korea
Visual assessment of lesion
Time frame: Day of study drug administration
Quantitative analysis of BAY94-9392 uptake into lesions (Standardized Uptake Values = SUVs)
Time frame: Day of study drug administration
Electrocardiogram (ECG)
Time frame: At least twice within 2 days after treatment
Blood pressure
Time frame: At least twice within 2 days after treatment
Serum protein
Time frame: At least twice within 2 days after treatment
Serum creatinine
Time frame: At least twice within 2 days after treatment
Serum GOT (Glutamate-Oxalacetate-Transaminase)
Time frame: At least twice within 2 days after treatment
Adverse events collection
Time frame: Continuously for at least 4 days after treatment
Radiation doses per organ (µGy/MBq)
Time frame: Day of study drug administration
Higher organ dose (HT)
Time frame: Day of study drug administration
Doses per organ (µSv/MBq)
Time frame: Day of study drug administration
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Effective dose (µSv/MBq)
Time frame: Day of study drug administration
Effective dose resulting from the total administered diagnostic activity of 300 MBq +/- 10%
Time frame: Day of study drug administration