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

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

Official Title
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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

Conditions
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Neoplasm

Intervention / Treatment
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* Drug: F-18 (BAY85-8050)
* Drug: F-18 (BAY85-8050)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: F-18 (BAY85-8050)<br>* Cancer patients, injection of BAY 85-8050, PET/CT<br>|
| Experimental: Arm 2<br> | Drug: F-18 (BAY85-8050)<br>* Healthy volunteers, injection of BAY 85-8050, whole body PET/CT for determination of effective dose, kinetics of BAY 85-8050 in blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual assessment of lesions |  | Within up to 2 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs) |  | Within up to 2 hours after treatment | 
| Serum chemistry:Glutamate pyruvate transaminase (GPT/ALAT), gamma-glutamyl transferase (gamma-GT), glutamate-oxaloacetate transaminase (GOT), alkaline phosphatase, total bilirubin, creatinine, total protein |  | At least 2 times within 8 days after treatment | 
| Electrocardiogram (ECG) |  | at least 2 times within 8 days after treatment | 
| Vital signs: Heart rate, blood pressure |  | at least 2 times within 8 days after treatment | 
| Adverse events collection |  | continuously for at least 8 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasm, PET/CT diagnosis, PET tracer