Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients
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
2 other identifiers
interventional
20
1 country
1
Brief Summary
This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2009
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2009
CompletedOctober 12, 2022
October 1, 2022
8 months
August 18, 2009
October 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual assessment of lesions
Within up to 2 hours after treatment
Secondary Outcomes (5)
Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs)
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 protein
At least 2 times within 8 days after treatment
Electrocardiogram (ECG)
at least 2 times within 8 days after treatment
Vital signs: Heart rate, blood pressure
at least 2 times within 8 days after treatment
Adverse events collection
continuously for at least 8 days after treatment
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
München, Bavaria, 81675, Germany
Related Links
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 19, 2009
Study Start
April 15, 2009
Primary Completion
December 16, 2009
Study Completion
December 16, 2009
Last Updated
October 12, 2022
Record last verified: 2022-10