Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-4367 in Patients With Prostate Cancer and Healthy Volunteers

Study Overview
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Brief Summary
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Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-4367 in patients with cancer

Official Title
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Open-label, Multicenter PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 18F Labeled PET Tracer BAY86-4367 Following a Single Intravenous Administration of 300 MBq (Corresponding to </= 40 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers

Conditions
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Diagnostic Imaging

Intervention / Treatment
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* Drug: BAY86-4367
* Drug: BAY86-4367


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers: males, >/=50 and <= 65 years of age Cancer patients: males >/= 45 years of age patients with recurrent prostate cancer had a positive choline PET/CT for detection, or staging, or restaging of cancer, evaluation of the primary prostate cancer detection rate with BAY 86-4367 in comparison to histology as standard of truth (choline PET/CT is optional). Exclusion Criteria: Exclusion criteria for all healthy volunteers and patients: 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 BAY 86-4367, 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: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

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: BAY86-4367<br>* Cancer patients, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, PET/CT<br>|
| Experimental: Arm 2<br> | Drug: BAY86-4367<br>* Healthy volunteers, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, whole body PET/CT for determination of effective dose., kinetics of BAY86-4367 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 |  | Day of study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative analysis of BAY86-4367 uptake into lesions (Standardized Uptake Values = SUVs) |  | Day of study drug administration | 
| Electrocardiogram (ECG) |  | At least 3 times within 8 days after treatment | 
| Blood pressure |  | At least 3 times within 8 days after treatment | 
| Serum protein |  | At least 3 times within 8 days after treatment | 
| Serum creatinine |  | At least 3 times within 8 days after treatment | 
| Serum GOT (Glutamat-Oxalacetat-Transaminase) |  | At least 3 times within 8 days after treatment | 
| Adverse events collection |  | At least 3 times within 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