drugset / Trial / 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.

NCT01297088 ↗

Phase 1 Completed 24 enrolled Lantheus Biosciences Ltd.
Non-randomizedSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2011-05
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject BAY86-9596 Diagnostic / imaging agent 300 mbq Intravenous

Indications

No indication recorded.