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Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation
Sponsor: Lantheus Biosciences Ltd.
Summary
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.
Official title: Open-label, Multi Center Study for an Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 100 µg Total Quantity) in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability, Pharmacokinetics, and Diagnostic Performance of the Tracer in PET/CT in Cancer Patients or Patients With Inflammation.
Key Details
Gender
All
Age Range
35 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2010-04
Completion Date
2011-08
Last Updated
2026-10-26
Healthy Volunteers
Yes
Conditions
Interventions
BAY94-9392
Locations (3)
Stanford, California, United States
München, Bavaria, Germany
Seoul, South Korea