NCT01186601

Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer

Open-label Study for an Exploration of Tumor Accumulation of the 18F Labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to </= 0.1 mg Total Quantity) in Patients With Prostate Cancer or Other Malignant Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Life Molecular Imaging SA · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The study will be conducted as an open label, single-dose, explorative study with patients with histologically proven cancer and, preferably, tumor positive lesions in previously performed nuclear medicine imaging examinations. The investigational drug will be given as a single administration in a dose of \</= 0.1 mg BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be approximately 8 days.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	PET tracer (BAY94-9392)	A radioactive dose of 300 MBq of the study drug with a total quantity of \</= 0.1 mg will be administered as slow intravenous bolus injection over up to 60 seconds

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-08-23
• Last updated: 2014-11-13

Locations

1 site across 1 country: United States