NCT01297088

PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.

Open-label, Single Center Study of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY86-9596 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 18 µg Mass Dose) for Evaluation of Biodistribution in Pathological Tissue in Patients With Cancer or Inflammation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Life Molecular Imaging SA · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study will be conducted as an open label, single-center, single dose and biodistribution study in patients with cancer or inflammation. 56 patients will be selected among the patients undergoing the screening examination conducted within 3 weeks before drug administration. Single dose of the study drug will be administrated in a dose of 300 MBq to these patients. The follow-up period contains the end-of-study telephone interview 5-8 days following the treatment. Key measurements are the PET/CT image acquisitions within a time frame of about 2 hours after the single injection of BAY86-9596.

Conditions

• Diagnostic Imaging

Interventions

Type	Name	Description
DRUG	BAY86-9596	One single dose administration of a diagnostic agent

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-02-16
• Last updated: 2013-01-21

Locations

2 sites across 1 country: Singapore