TheranosticTrials.org

Clinical Trial · NCT01788280

Preliminary Assessment of [18F] Fluciclatide (GE [18F]AH111585) in Glioblastoma Multiforme Treated With Bevacizumab

Overview

This exploratory study uses \[18F\] Fluciclatide and Positron emission tomography (PET) imaging in patients with glioblastoma multiforme (GBM) to be treated with Bevacizumab. The primary objective of this study is to determine the association of \[18F\] Fluciclatide uptake, fludeoxyglucose (FDG) uptake, and tumor blood flow/perfusion determined with H215O and Magnetic resonance imaging (MRI) and correlate these variables with time to progression (TTP) in participants with GBM treated with Bevacizumab.

Sponsor

University of Utah

Phase

Phase 2

Contacts

John Hoffman, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01788280

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Fluciclatide

Isotope(s):
Target(s):
  • αvβ3
Ligand Class: Small Proteins and Antibody Fragments

Eligibility

Inclusion

  • The patient must have a histologically proven GBM, and are scheduled to be treated with Avastin therapy.
  • Patients must agree to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database, as evidenced by signing the informed consent form.
  • Patient has a tumor volume of \> 2.0 cm in greatest diameter is required to assess response to therapy.
  • An anatomic imaging study (MRI of the brain) must be current and have been obtained within 28 days prior to the research PET imaging studies.
  • * Patients must be 18 years or older for inclusion in this research study. There is inadequate experience with the safety of \[18F\] Fluciclatide (GE \[18F\]AH111585) in children and therefore this radiopharmaceutical should not be used in patients under the age of 18.

Exclusion

  • Patients who are too claustrophobic to undergo MRI or PET imaging.
  • Adult patients who require monitored anesthesia for PET scanning.
  • Patients known to be HIV positive. This is due to the unknown potential toxicities of Fluciclatide in HIV positive patients.
  • * Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
  • Patients with a calculated GFR of less than 30 ml/min will be excluded from the study. For a GFR between 30-60 ml/min the MRI will be possible (using half the usual administered dose of contrast) at the discretion of the study doctor. If the patient does not wish to undergo an MRI due to their renal function they will be excluded from the study.