Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430079
Status:
TERMINATED
Last Update Posted:
2013-01-16
First Post:
2007-01-30
Brief Title:
Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Assessment of Hypoxia in Malignant Gliomas Using EF5
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 clinical trial is using EF5 to measure the oxygen level in tumor cells of patients undergoing surgery or surgery biopsy for newly diagnosed supratentorial malignant glioma Diagnostic procedures using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment
Detailed Description:
PRIMARY OBJECTIVES
I Determine the presence and pattern of etanidazole derivative EF5 binding with tumor based on image and cellular analyses in patients undergoing surgery or biopsy for newly diagnosed supratentorial malignant gliomas
II Determine the level of EF5 binding within histologic subtypes of this tumor in these patients
Compare the relationship between hypoxia and clinical outcomes in patients with glioblastoma multiforme GBM vs non-GBM
III Determine the spatial relationships between EF5 binding and tumor tissue biomarkers and pathophysiologic processes eg necrosis proliferation and apoptosis in these patients
IV Determine the relationship between EF5 binding and Eppendorf needle electrode measurements in these patients
OUTLINE
Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy Tumor tissue normal tissue andor tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers Fluorescent immunohistochemistry techniques are used to determine the presence distribution and levels of EF5 binding
Patients are followed at 1 month every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study within 1½-2 years
I Determine the presence and pattern of etanidazole derivative EF5 binding with tumor based on image and cellular analyses in patients undergoing surgery or biopsy for newly diagnosed supratentorial malignant gliomas
II Determine the level of EF5 binding within histologic subtypes of this tumor in these patients
Compare the relationship between hypoxia and clinical outcomes in patients with glioblastoma multiforme GBM vs non-GBM
III Determine the spatial relationships between EF5 binding and tumor tissue biomarkers and pathophysiologic processes eg necrosis proliferation and apoptosis in these patients
IV Determine the relationship between EF5 binding and Eppendorf needle electrode measurements in these patients
OUTLINE
Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy Tumor tissue normal tissue andor tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers Fluorescent immunohistochemistry techniques are used to determine the presence distribution and levels of EF5 binding
Patients are followed at 1 month every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study within 1½-2 years
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 |
|---|---|---|---|
| CDR0000068962 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchR21CA093007 |
| UPCC 1301 | None | None | None |
| R21CA093007 | NIH | None | None |