Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors
I. Determine the safety of fluorine F 18 EF5 (^18F-EF5) in patients with newly diagnosed
brain tumors undergoing surgery or biopsy.
Secondary I. Determine the pharmacokinetics and biodistribution of ^18F-EF5 administered
before and after nonradioactive EF5 in these patients.
II. Determine the ability of positron emission tomography (PET) scanning using ^18F-EF5 to
detect tumor hypoxia in these patients.
III. Determine the presence and pattern of nonradioactive EF5 binding by
immunohistochemistry (IHC) and/or flow cytometry in these patients.
IV. Correlate tumor hypoxia, as measured by PET scanning using ^18F-EF5, with EF5 staining
by IHC and/or flow cytometry and recurrence-free survival of these patients.
OUTLINE: Patients are assigned to 1 of 3 groups.
Group 1: Patients receive fluorine F 18 EF5 (^18F-EF5) IV followed by whole brain and whole
body positron emission tomography (PET) scanning OR whole body PET scanning only. Patients
then receive nonradioactive EF5 IV over 1-2 ½ hours.
Group 2: Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV.
Patients then undergo whole brain and whole body PET scanning.
Group 3: Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then
undergo whole brain PET scanning. Approximately one day after EF5 administration, all
patients undergo surgery or biopsy of the tumor AND biopsy of normal skin adjacent to the
Patients are followed at 2-4 weeks and 4-6 weeks after EF5 administration and then every 3
months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Safety of F-18-EF5 based on the NCI CTCAE version 3.0
Summarized in descriptive statistics.
Up to 3 years
Stephen Michael Hahn
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
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