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Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00961831
First received: August 18, 2009
Last updated: February 16, 2013
Last verified: February 2013
History of Changes

August 18, 2009
February 16, 2013
April 2009
December 2009   (final data collection date for primary outcome measure)
Visual assessment of lesions [ Time Frame: Within up to 2 hours after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00961831 on ClinicalTrials.gov Archive Site
  • Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs) [ Time Frame: Within up to 2 hours after treatment ] [ Designated as safety issue: No ]
  • Serum chemistry:Glutamate pyruvate transaminase (GPT/ALAT), gamma-glutamyl transferase (gamma-GT), glutamate-oxaloacetate transaminase (GOT), alkaline phosphatase, total bilirubin, creatinine, total protein [ Time Frame: At least 2 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Electrocardiogram (ECG) [ Time Frame: at least 2 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Vital signs: Heart rate, blood pressure [ Time Frame: at least 2 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Adverse events collection [ Time Frame: continuously for at least 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs) [ Time Frame: Within up to 2 hours after treatment ] [ Designated as safety issue: No ]
  • Serum chemistry:Glutamate pyruvate transaminase (GPT/ALAT), gamma-glutamyl transferase (gamma-GT), glutamate-oxaloacetate transaminase (GOT), alkaline phosphatase, total bilirubin, creatinine, total protein [ Time Frame: At least 3 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: at least 3 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Vital signs: Heart rate, blood pressure [ Time Frame: at least 3 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Adverse events collection [ Time Frame: continuously for at least 8 days after treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Neoplasm
  • Drug: F-18 (BAY85-8050)
    Cancer patients, injection of BAY 85-8050, PET/CT
  • Drug: F-18 (BAY85-8050)
    Healthy volunteers, injection of BAY 85-8050, whole body PET/CT for determination of effective dose, kinetics of BAY 85-8050 in blood
  • Experimental: Arm 1
    Intervention: Drug: F-18 (BAY85-8050)
  • Experimental: Arm 2
    Intervention: Drug: F-18 (BAY85-8050)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
35 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00961831
13107, 2008-000962-21
No
Head Clinical Pharmacology, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP