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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Piramal Imaging SA


  • Drug: PET tracer (BAY94-9392)


Phase 1


Inclusion 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.

Exclusion Criteria:

   - 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


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
Not Recruiting