Trial Condition(s):
Diagnostic Imaging
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
Bayer Identifier:
13991
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Universitätsspital Zürich Zürich, Switzerland, 8091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum rechts der Isar München, Germany, 81675 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Visual assessment of lesionsTimeframe: Day of study drug administration
Secondary Outcome
- Quantitative analysis of BAY86-4367 uptake into lesions (Standardized Uptake Values = SUVs)Timeframe: Day of study drug administration
- Electrocardiogram (ECG)Timeframe: At least 3 times within 8 days after treatment
- Blood pressureTimeframe: At least 3 times within 8 days after treatment
- Serum proteinTimeframe: At least 3 times within 8 days after treatment
- Serum creatinineTimeframe: At least 3 times within 8 days after treatment
- Serum GOT (Glutamat-Oxalacetat-Transaminase)Timeframe: At least 3 times within 8 days after treatment
- Adverse events collectionTimeframe: At least 3 times within 8 days after treatment
Additional Information
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