PET/CT imaging study for evaluation of safety and tolerability and diagnostic performance of BAY1075553 in patients with prostate cancer and in healthy volunteers
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
14
Cancer patients, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1
Healthy volunteers for dosimetry, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1
Unnamed facility
Ann Arbor, Michigan, United States
Unnamed facility
Linz, Austria
Safety parameters, for example laboratory and electrocardiogram abnormalities
Time frame: Day 2
Effective radiation dose given in mSv (milliSievert) in healthy volunteers
Time frame: Day 1
Overall lesion detection rate
Time frame: Day 1
Lesion detection rate in comparison to histology, where available (cancer lesion detection rate)
Time frame: Day 1
Lesion detection rate in comparison to MRI (Magnetic Resonance Imaging) and/or [11C] (11Carbon)- or [18F] (18Fluor)-choline PET/CT (whenever available)
Time frame: Day 1
Accumulation score in all lesions identified with BAY1075553
Time frame: Day 1
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