NCT00961831

Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients

Open-label, Multicenter Study for an Evaluation of Radiation Dosimetry, Metabolism, Safety and Tolerability of the [F18] Labeled PET (Positron Emission Tomography) Tracer BAY 85-8050 Following a Single Intravenous Administration in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability and Diagnostic Performance of the Tracer in PET/CT (Computer Tomography) in Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer

Conditions

• Neoplasm

Interventions

Type	Name	Description
DRUG	F-18 (BAY85-8050)	Cancer patients, injection of BAY 85-8050, PET/CT
DRUG	F-18 (BAY85-8050)	Healthy volunteers, injection of BAY 85-8050, whole body PET/CT for determination of effective dose, kinetics of BAY 85-8050 in blood

Timeline

• Start date: 2009-04-15
• Primary completion: 2009-12-16
• Completion: 2009-12-16
• First posted: 2009-08-19
• Last updated: 2022-10-12

Locations

1 site across 1 country: Germany