Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer

Not Recruiting

Trial ID: NCT01186601

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

Stanford Investigator(s)

Andrei Iagaru
Andrei Iagaru

Professor of Radiology (Nuclear Medicine)

Eligibility


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

Intervention(s):

drug: PET tracer (BAY94-9392)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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