PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 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 BAY86-7548 in patients with cancer.

Official Title
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Open-label, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 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: Bombesin (68Ga) labeled (BAY86-7548)
* Drug: Bombesin (68Ga) labeled (BAY86-7548)


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 had an MRI of the prostate and/or a positive choline or acetate PET/CT for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary prostate cancer patients) of recurrence prostate cancer and the primary cancer disease is/ will be histologically confirmed. The prostate cancer is histologically confirmed and results of histology are available. Patients with primary prostate cancer: >/= 20 percent of biopsy material should be affected by cancer in the histopathological evaluation. Patients with primary prostate cancer: Patient is scheduled to undergo prostatectomy. 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 BAY86-7548, 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Bombesin (68Ga) labeled (BAY86-7548)<br>* Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT<br>|
| Experimental: Arm 2<br> | Drug: Bombesin (68Ga) labeled (BAY86-7548)<br>* Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY86-7548 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 BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs) |  | Day of study drug administration | 
| ECG (significant abnormalities) |  | At least 3 times until one day after treatment | 
| Blood pressure |  | At least 3 times until one day after treatment | 
| Serum protein |  | At least 3 times until one day after treatment | 
| Serum creatinine |  | At least 3 times until one day after treatment | 
| Serum GOT (Glutamat-Oxalacetat-Transaminase) |  | At least 3 times until one day after treatment | 
| Adverse events collection |  | Continuously for at least 5 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