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PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations
Sponsor: Lantheus Biosciences Ltd.
Summary
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
Official title: Open-label, Multicenter Study of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY86-9596 Following a Single Intravenous Administration of 200 or 300 MBq (Corresponding to ≤ 18 µg Mass Dose) for Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers (200 MBq) as Well as Investigation of Safety, Tolerability and Diagnostic Performance in Patients (300 MBq) With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and in Patients With Inflammation.
Key Details
Gender
All
Age Range
30 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2010-05
Completion Date
2011-09
Last Updated
2026-10-26
Healthy Volunteers
Yes
Conditions
Interventions
BAY86-9596
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
BAY86-9596
Cancer patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
BAY86-9596
Inflammation patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
Fludeoxyglucose (18F)-IBA
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)
Locations (2)
Groningen, Provincie Groningen, Netherlands
Zurich, Canton of Zurich, Switzerland