Open-label, Single Center Study of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY86-9596 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 18 µg Mass Dose) for Evaluation of Biodistribution in Pathological Tissue in Patients With Cancer or Inflammation
- Cancer Patients
- Patient had an Fluorodeoxyglucose (FDG) Positron Emission Tomography
(PET)/Computer tomography(CT) performed 14 days prior to treatment with
BAY86-9596 for detection, or staging, or restaging, or therapy response
assessment that still showed tumor mass with high certainty, for cancers such as
- Colorectal cancer,
- Breast cancer (female patients),
- Hepatocellular carcinoma (HCC) and the cancers under colorectal cancer to
hepatocellular carcinoma (HCC) are histologically confirmed (Exception,
based on diagnostic criteria for the management of hepatocellular
carcinoma: Histological diagnosis of hepatocelluar carcinoma is not
necessary if the nodule is larger than 2 cm, has been visualized in two
dynamic imaging studies and shows arterial hyperenhancement and washes out
in the venous phase.)
- Patient has prostate cancer (primary or recurrent), still shows tumor mass
(primary tumor and/or lymph node metastasis and/or distant metastasis) and the
primary cancer disease is histologically confirmed
- Patient has brain metastasis (strong evidence from imaging modalities), and the
primary cancer disease is histologically confirmed.
- Patient has a primary malignant brain tumor which is either confirmed by
histology, or a positive cytology of cerebrospinal fluid, or imaging modalities
(such as MRI, CT) strongly support the diagnosis of brain tumor.
- Patient has some other cancer (such as ovarian cancer, melanoma), preferably
with an FDG PET/CT available, and the primary cancer is histologically
- Inflammation Patients
- Patient with inflammatory disease having inflammatory focus/foci. An FDG PET/CT
of the inflammation is available.
- Patient underwent FDG PET/CT during the inflammation. The maximum interval
between FDG PET/CT and examination with BAY86-9596 is 5 days, performance of
both examinations on two subsequent days is recommended.
- 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 BAY86-9596,
unstable and uncontrolled hypertension, severe pulmonary disease, chronic renal or
hepatic disease which could compromise participation in the study. When considering
hepatic function in hepatocellular cancer patients, the Child-Pugh score is applied,
a score > 7 will be considered an exclusion criterion.
- Known sensitivity to the study drug or components of the preparation
- Drug abuse/dependence or history of recovered alcohol dependence.
- Patient has completed participation in another clinical study involving
administration of an investigational drug in the preceding 4 weeks or is
participating in any other clinical trial during this study
- Previous participation in treatment phase in this study
- Unwillingness or inability to comply with the protocol
- Patient fulfils criteria which in the opinion of the investigator preclude
participation for scientific reasons, for reasons of compliance, or for reasons of
the patient's safety.
- Patients with inflammatory disease with known tumor where images of tumor lesions may
overlap with inflammatory lesions, or tumor patients with known inflammatory diseases
(e.g. autoimmune diseases), where images of inflammatory lesions may overlap with