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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions

Diagnostic Imaging

Interventions

DRUG

BAY86-9596

Healthy volunteers, single intravenous bolus injection of 200 MBq BAY 86-9596 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY 86-9596 in blood and urine

DRUG

BAY86-9596

Cancer patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.

DRUG

BAY86-9596

Inflammation patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.

DRUG

Fludeoxyglucose (18F)-IBA

Subgroup of cancer patients: radiation induced inflammation. Fluordeoxyglucose (18F)-FDG PET scan will be performed approx. 4 week after radiation and compared with tracer BAY86-9596 (acc. to Amendment 4 only in the Netherlands)

Trial Locations (2)

8091

Zurich

9713 GZ

Groningen