Exploration of tumor accumulation of BAY94-9392 in patients with cancer
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.
- Males/females >/= 18 years - Patients with a diagnosis of primary prostate cancer (biopsy proven) and scheduled for radical prostatectomy or patients with prostate tumor recurrence (Patients with advanced tumor disease and a high likelihood to display lymph node metastasis are to be preferably included.) - ECOG (Eastern Cooperative Oncology Group) performance status of 0-2, determined within one week prior to treatment with BAY94-9392 - Patient had an [18F]-fluorodeoxyglucose (FDG) PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty for a cancer such as melanoma, or colorectal cancer, or head & neck cancer for which FDG-PET/CT is used in clinical routine, and the primary cancer disease is histologically confirmed. In case of recurrent disease confirmation of the primary tumor is sufficient - No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
- Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY94-9392, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study - Known sensitivity to the study drug or components of the preparation - Previous treatment with BAY94-9392 in this study
Stanford Hospital & Clinics
Stanford, United States, 94305
E-mail: [email protected]
Phone: Not Available
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
Single Group Assignment