Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-02 @ 9:55 AM
Study NCT ID:
NCT00110032
Status:
TERMINATED
Last Update Posted:
2013-01-16
First Post:
2005-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography Using Fluorine F 18 EF5 to Find Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Newly Diagnosed Brain Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial is studying the side effects of fluorine F18 EF5 when given during positron emission tomography to find oxygen in tumor cells of patients who are undergoing surgery or biopsy for newly diagnosed brain tumors. Diagnostic procedures using fluorine F 18 EF5 and positron emission tomography to detect tumor hypoxia may help in planning cancer treatment
Detailed Description:
PRIMARY OBJECTIVES:
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 incision.
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 thereafter.
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 incision.
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 thereafter.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: