NCT01205321

PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers

Open-label, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Life Molecular Imaging SA · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.

Conditions

• Diagnostic Imaging

Interventions

Type	Name	Description
DRUG	Bombesin (68Ga) labeled (BAY86-7548)	Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT
DRUG	Bombesin (68Ga) labeled (BAY86-7548)	Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY86-7548 in blood

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2010-09-20
• Last updated: 2013-01-21

Locations

3 sites across 3 countries: Finland, Germany, Switzerland