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

Bayer

Status and phase: Completed; Phase 1

Conditions: Neoplasm

Treatments: Drug: F-18 (BAY85-8050)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00961831

13107

2008-000962-21 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers only
• Males/females, >/=50 and </= 65 years of age
• Cancer patients only
• Males/females >/= 35 years and </= 75 years of age
• Patient had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass

Exclusion criteria

• Concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY85-8050, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
• Known sensitivity to the study drug or components of the preparation

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: F-18 (BAY85-8050)

Drug: F-18 (BAY85-8050)

Arm 2

Experimental group

Treatment:

Drug: F-18 (BAY85-8050)

Drug: F-18 (BAY85-8050)