XCancer

PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.

Description:

The study will be conducted as an open label, single-center, single dose and biodistribution study in patients with cancer or inflammation. 56 patients will be selected among the patients undergoing the screening examination conducted within 3 weeks before drug administration. Single dose of the study drug will be administrated in a dose of 300 MBq to these patients. The follow-up period contains the end-of-study telephone interview 5-8 days following the treatment. Key measurements are the PET/CT image acquisitions within a time frame of about 2 hours after the single injection of BAY86-9596.

Sponsor:

Unknown Organization

Phase:

Phase 1

Contacts:

Bayer Study Director (STUDY_DIRECTOR)

Government Study Link:

NCT01297088 - Click here to see study on

ClinicalTrials.gov

BAY86-9596

Isotope(s):
Target(s):
  • LAT1/LAT2
Inclusion
  • Breast cancer (female patients),
  • Colorectal cancer,
  • * 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
  • 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.)
Exclusion
  • * 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.
  • 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
  • Known sensitivity to the study drug or components of the preparation
  • Drug abuse/dependence or history of recovered alcohol dependence.