TheranosticTrials.org
Bayer

Clinical Trial · NCT00961831

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

Overview

This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer

Sponsor

Bayer

Phase

Phase 1

Contacts

Bayer Study Director (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT00961831

Drug / Compound

BAY85-8050

Isotope(s):
Target(s):
  • Glutaminolytic Activity

Eligibility

Inclusion

  • Males/females, \>/=50 and \</= 65 years of age
  • Cancer patients only
  • Males/females \>/= 35 years and \</= 75 years of age
  • * Healthy volunteers only
  • Patient had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass

Exclusion

  • * 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

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

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