Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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 \
Official Title
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
Eligibility Criteria
- * 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
