Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation

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 BAY94-9392 in patients with cancer or inflammation.

Official Title
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Open-label, Multi Center Study for an Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 100 µg Total Quantity) in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability, Pharmacokinetics, and Diagnostic Performance of the Tracer in PET/CT in Cancer Patients or Patients With Inflammation.

Conditions
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Diagnostic Imaging, Neoplasms

Intervention / Treatment
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* Drug: BAY94-9392


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: In Germany Healthy volunteers Males/females ≥ 50 and ≤ 65 years Patients Males/females ≥ 35 and ≤ 75 years histologically confirmed diagnosis of non small cell lung cancer or adenocarcinoma of the breast with a positive FDG-PET or patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or inflammation with a positive FDG-PET In Korea Patients Males/females ≥ 35 and ≤ 75 years histologically confirmed diagnosis of non small cell lung cancer, adenocarcinoma of the breast or hepatocellular cancer with a positive FDG-PET or patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or inflammation (positive FDG-PET mandatory, could be also done as screening examination) Exclusion criteria: Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY 94-9392, 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>Cancer patients, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, PET/CT | Drug: BAY94-9392<br> <br> |
| Experimental: Arm 2<br>Healthy volunteers, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY94-9392 in blood | Drug: BAY94-9392<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual assessment of lesion |  | Day of study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative analysis of BAY94-9392 uptake into lesions (Standardized Uptake Values = SUVs) |  | Day of study drug administration | 
| Electrocardiogram (ECG) |  | At least twice within 2 days after treatment | 
| Blood pressure |  | At least twice within 2 days after treatment | 
| Serum protein |  | At least twice within 2 days after treatment | 
| Serum creatinine |  | At least twice within 2 days after treatment | 
| Serum GOT (Glutamate-Oxalacetate-Transaminase) |  | At least twice within 2 days after treatment | 
| Adverse events collection |  | Continuously for at least 4 days after treatment | 
| Radiation doses per organ (µGy/MBq) |  | Day of study drug administration | 
| Higher organ dose (HT) |  | Day of study drug administration | 
| Doses per organ (µSv/MBq) |  | Day of study drug administration | 
| Effective dose (µSv/MBq) |  | Day of study drug administration | 
| Effective dose resulting from the total administered diagnostic activity of 300 MBq +/- 10% |  | Day of study drug administration | 

 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