Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028782
Status:
TERMINATED
Last Update Posted:
2013-01-16
First Post:
2002-01-04
Brief Title:
EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
The Detection of Tumor Hypoxia and Vascularity in Patients Undergoing Intraperitoneal Photodynamic Therapy
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 II trial is studying how well EF5 works in detecting oxygen level and blood vessels in tumor cells of patients who are undergoing photodynamic therapy for intraperitoneal or pleural cancer Diagnostic procedures using EF5 to detect oxygen level and blood vessels in tumor cells may help to improve the way photodynamic therapy is given
Detailed Description:
OBJECTIVES
I Determine the level of hypoxia through etanidazole derivative EF5 binding in patients with intraperitoneal or pleural malignancies treated with photodynamic therapy
II Determine the microvascular density in this patient population III Determine the relationships between levels of hypoxia measures of microvascular density and photosensitizer levels in this patient population
IV Correlate hypoxia and photosensitizer levels with clinical outcome in this patient population
V Determine the toxic effects of EF5 in this patient population
OUTLINE This is a multicenter study
Patients receive etanidazole derivative EF5 IV over 1-2 hours Approximately 48 hours after EF5 administration patients with intraperitoneal tumors undergo surgical resection Patients with pleural tumors undergo surgical resection approximately 24 hours after EF5 administration Tumors are then analyzed for EF5 binding and microvascular density by immunohistochemistry and fluorescent antibody techniques
Patients are followed at 2 weeks and at 30-45 days post EF5 infusion
PROJECTED ACCRUAL A total of 80 patients 50 with intraperitoneal malignancy and 30 with pleural malignancy will be accrued for this study within 25 years Patients are stratified by disease intraperitoneal malignancy vs pleural malignancy
I Determine the level of hypoxia through etanidazole derivative EF5 binding in patients with intraperitoneal or pleural malignancies treated with photodynamic therapy
II Determine the microvascular density in this patient population III Determine the relationships between levels of hypoxia measures of microvascular density and photosensitizer levels in this patient population
IV Correlate hypoxia and photosensitizer levels with clinical outcome in this patient population
V Determine the toxic effects of EF5 in this patient population
OUTLINE This is a multicenter study
Patients receive etanidazole derivative EF5 IV over 1-2 hours Approximately 48 hours after EF5 administration patients with intraperitoneal tumors undergo surgical resection Patients with pleural tumors undergo surgical resection approximately 24 hours after EF5 administration Tumors are then analyzed for EF5 binding and microvascular density by immunohistochemistry and fluorescent antibody techniques
Patients are followed at 2 weeks and at 30-45 days post EF5 infusion
PROJECTED ACCRUAL A total of 80 patients 50 with intraperitoneal malignancy and 30 with pleural malignancy will be accrued for this study within 25 years Patients are stratified by disease intraperitoneal malignancy vs pleural malignancy
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 |
|---|---|---|---|
| UPCC 05901 | None | None | None |
| P01CA087971 | NIH | None | None |
| CDR0000069134 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchP01CA087971 |