Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049140
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
2002-11-12
Brief Title:
EF5 Compared With Other Methods of Detecting Oxygen Levels in Tumor Cells of Patients With Head and Neck Cancer
Sponsor:
David M Brizel MD
Organization:
Duke University
Study Overview
Official Title:
Pilot Study of the Relationship Between EF5 Uptake and Concentration of Oxygen-Related Metabolites in Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors
PURPOSE Phase II trial to compare diagnostic procedures using EF5 to that of other methods of detecting oxygen levels in tumor cells of patients who have head and neck cancer
PURPOSE Phase II trial to compare diagnostic procedures using EF5 to that of other methods of detecting oxygen levels in tumor cells of patients who have head and neck cancer
Detailed Description:
OBJECTIVES
Determine the distribution degree and intrapatient and interpatient heterogeneity of hypoxia as measured by EF5 binding in tumor tissue in patients with head and neck cancer
Determine the distribution and intrapatient and interpatient heterogeneity of CA9 expression as measured immunohistochemically in these patients
Determine the distribution concentration and intrapatient and interpatient heterogeneity of glucose and lactate as measured by bioluminescence imaging in these patients
Determine whether there is spatial coordination between concentrations of lactate and glucose and the location of tissue hypoxia in these patients
Determine whether there is spatial coordination between the location of CA9 with hypoxia andor lactate concentrations in these patients
OUTLINE Patients receive EF5 IV over 1-25 hours on day 1 Within 24-55 hours after EF5 infusion patients undergo surgery
Tumor tissue samples are examined for EF5 binding by immunohistochemistry bioluminescence imaging and flow cytometry
Patients are followed at 1 month and then for survival
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study within 1 year
Determine the distribution degree and intrapatient and interpatient heterogeneity of hypoxia as measured by EF5 binding in tumor tissue in patients with head and neck cancer
Determine the distribution and intrapatient and interpatient heterogeneity of CA9 expression as measured immunohistochemically in these patients
Determine the distribution concentration and intrapatient and interpatient heterogeneity of glucose and lactate as measured by bioluminescence imaging in these patients
Determine whether there is spatial coordination between concentrations of lactate and glucose and the location of tissue hypoxia in these patients
Determine whether there is spatial coordination between the location of CA9 with hypoxia andor lactate concentrations in these patients
OUTLINE Patients receive EF5 IV over 1-25 hours on day 1 Within 24-55 hours after EF5 infusion patients undergo surgery
Tumor tissue samples are examined for EF5 binding by immunohistochemistry bioluminescence imaging and flow cytometry
Patients are followed at 1 month and then for survival
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| NCI-5929 | None | None | None |
| DUMC-3512-02-3 | None | None | None |