TheranosticTrials.org

Clinical Trial · NCT01089998

PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations

Overview

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-9596 in patients with cancer and inflammation

Sponsor

Unknown Organization

Phase

Phase 1

Contacts

Bayer Study Director (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT01089998

Drug / Compound

BAY86-9596

Isotope(s):
Target(s):
  • PD-L1
Ligand Class: Small Molecules

BAY86-9596

Isotope(s):
Target(s):
  • PD-L1
Ligand Class: Small Molecules

BAY86-9596

Isotope(s):
Target(s):
  • PD-L1
Ligand Class: Small Molecules

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Cancer patients and inflammation patients (inflammation patients in study part 2 = optional, in study part 3 mandatory)
  • Males/females ≥ 50 years and ≤ 65 years of age
  • patients had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for
  • * Healthy volunteers only
  • Males/females ≥ 30 and ≤ 80 years of age

Exclusion

  • * Exclusion criteria for all healthy volunteers and patients:
  • any concomitant disease (for healthy volunteers) and for patients any 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 BAY86-9596, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
  • For healthy volunteers and patients: known sensitivity to the study drug or components of the preparation.
  • tumor patients with known inflammatory disease, where images overlap inflammatory lesions with tumor lesions