Trial Condition(s):
Neoplasm
Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients
Bayer Identifier:
13107
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Inclusion Criteria
- Healthy volunteers only - Males/females, >/=50 and </= 65 years of age - Cancer patients only - Males/females >/= 35 years and </= 75 years of age - Patient had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass
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 BAY85-8050, 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 | Status | |
|---|---|---|
Locations Investigative Site München, Germany, 81675 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open-label, multicenter study for an evaluation of radiation dosimetry, metabolism, safety and tolerability of the [F18] labeled PET (positron emission tomography) tracer BAY 85-8050 following a single intravenous administration in healthy volunteers, as well as the investigation of safety, tolerability and diagnostic performance of the tracer in PET/CT (computer tomography) in patients
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: Within up to 2 hours after treatment
Secondary Outcome
- Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs)Timeframe: Within up to 2 hours after treatment
- Serum chemistry:Glutamate pyruvate transaminase (GPT/ALAT), gamma-glutamyl transferase (gamma-GT), glutamate-oxaloacetate transaminase (GOT), alkaline phosphatase, total bilirubin, creatinine, total proteinTimeframe: At least 2 times within 8 days after treatment
- Electrocardiogram (ECG)Timeframe: at least 2 times within 8 days after treatment
- Vital signs: Heart rate, blood pressureTimeframe: at least 2 times within 8 days after treatment
- Adverse events collectionTimeframe: continuously for at least 8 days after treatment
Additional Information
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