Trial Search Results
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.
Stanford is currently not accepting patients for this trial.
Piramal Imaging SA
- Drug: PET tracer (BAY94-9392)
- 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
Ages Eligible for Study
18 Years - 90 Years
Genders Eligible for Study