check_circleStudy Completed
Neoplasm
Bayer Identifier:
13107
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients
Trial purpose
This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer
Key Participants Requirements
Sex
BothAge
35 - 75 YearsTrial summary
Enrollment Goal
20Trial Dates
April 2009 - December 2009Phase
Phase 1Could I Receive a placebo
NoProducts
F18 Glutamic Acid (BAY85-8050)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | München, 81675, Germany |
Primary Outcome
- Visual assessment of lesionsdate_rangeTime Frame:Within up to 2 hours after treatmentenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs)date_rangeTime Frame:Within up to 2 hours after treatmentenhanced_encryptionnoSafety Issue:
- Serum chemistry:Glutamate pyruvate transaminase (GPT/ALAT), gamma-glutamyl transferase (gamma-GT), glutamate-oxaloacetate transaminase (GOT), alkaline phosphatase, total bilirubin, creatinine, total proteindate_rangeTime Frame:At least 2 times within 8 days after treatmentenhanced_encryptionyesSafety Issue:
- Electrocardiogram (ECG)date_rangeTime Frame:at least 2 times within 8 days after treatmentenhanced_encryptionyesSafety Issue:
- Vital signs: Heart rate, blood pressuredate_rangeTime Frame:at least 2 times within 8 days after treatmentenhanced_encryptionyesSafety Issue:
- Adverse events collectiondate_rangeTime Frame:continuously for at least 8 days after treatmentenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2