©2024 Stanford Medicine
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
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