Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00110032
Status:
TERMINATED
Last Update Posted:
2013-01-16
First Post:
2005-05-03
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:
National Cancer Institute NCI
Study Overview
Official Title:
Microenvironment ImagingImplications 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 andor flow cytometry in these patients
IV Correlate tumor hypoxia as measured by PET scanning using 18F-EF5 with EF5 staining by IHC andor 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 andor flow cytometry in these patients
IV Correlate tumor hypoxia as measured by PET scanning using 18F-EF5 with EF5 staining by IHC andor 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000423313 | REGISTRY | PDQ Physician Data Query | None |
| UPCC 01304 | None | None | None |