Nuclear Medicine & Molecular Imaging Clinical Trials
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 patientswith histologically proven cancer and, preferably, tumor positive lesions in previouslyperformed 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. For more information, please contact Lindee Burton at 6507254712 .
Lead Sponsor:
Piramal Imaging SA
Stanford Investigator(s):
Intervention(s):
- Drug: PET tracer (BAY94-9392)
Phase:
Phase 1
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
Ages Eligible for Study
18 Years - 90 Years
Genders Eligible for Study
Both
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Lindee Burton
6507254712
Not Recruiting