Clinical Trial · NCT01297088

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

Overview

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)

ClinicalTrials.gov

NCT01297088

Drug / Compound

BAY86-9596

Isotope(s):

Target(s):

LAT1/LAT2

Eligibility

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.