stop_circleTerminated/Withdrawn
Diagnostic imaging
Bayer Identifier:
13991
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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
Key Participants Requirements
Sex
MaleAge
45 YearsTrial summary
Enrollment Goal
16Trial Dates
September 2009 - October 2010Phase
Phase 1Could I Receive a placebo
NoProducts
Bombesin (18F) labeled (BAY86-4367)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Universitätsspital Zürich | Zürich, 8091, Switzerland |
Completed | Klinikum rechts der Isar | München, 81675, Germany |
Primary Outcome
- Visual assessment of lesionsdate_rangeTime Frame:Day of study drug administrationenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Quantitative analysis of BAY86-4367 uptake into lesions (Standardized Uptake Values = SUVs)date_rangeTime Frame:Day of study drug administrationenhanced_encryptionnoSafety Issue:
- Electrocardiogram (ECG)date_rangeTime Frame:At least 3 times within 8 days after treatmentenhanced_encryptionyesSafety Issue:
- Blood pressuredate_rangeTime Frame:At least 3 times within 8 days after treatmentenhanced_encryptionyesSafety Issue:
- Serum proteindate_rangeTime Frame:At least 3 times within 8 days after treatmentenhanced_encryptionyesSafety Issue:
- Serum creatininedate_rangeTime Frame:At least 3 times within 8 days after treatmentenhanced_encryptionyesSafety Issue:
- Serum GOT (Glutamat-Oxalacetat-Transaminase)date_rangeTime Frame:At least 3 times within 8 days after treatmentenhanced_encryptionyesSafety Issue:
- Adverse events collectiondate_rangeTime Frame:At least 3 times within 8 days after treatmentenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2