Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038038
Status:
WITHDRAWN
Last Update Posted:
2012-08-01
First Post:
2002-05-24
Brief Title:
Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
Status:
WITHDRAWN
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants enrolled study terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical research study is to answer the following questions using 18F-fluoromisonidazole as an imaging agent
1 Do cells exist in human tumors that are at very low oxygen levels hypoxic cells
2 If hypoxic cells exist in human tumors do they effect the ability of radiotherapy to control human tumors
3 Can Positron Emission Tomography PET scanning detect hypoxic cells in human tumors
1 Do cells exist in human tumors that are at very low oxygen levels hypoxic cells
2 If hypoxic cells exist in human tumors do they effect the ability of radiotherapy to control human tumors
3 Can Positron Emission Tomography PET scanning detect hypoxic cells in human tumors
Detailed Description:
Hypoxic low oxygen cells have long been known to exist in animal tumors It is also known that hypoxic cells are more difficult to eliminate with radiotherapy than tumor cells at normal levels of oxygen normoxic cells However the extent to which hypoxic cells limit the curability of human tumors is uncertain To determine if hypoxic cells exist in human tumors and how hypoxic cells might influence the efficacy of radiotherapy this study involves direct measurements of oxygen levels in human tumors compared to the tumor uptake of the experimental drug 18F-fluoromisonidazole 18F-FMISO visualized with PET scanning 18F-fluoromisonidazole has been used with PET imaging to tell the difference between growing tumors which have high and low oxygen content
Before beginning radiotherapy a PET scan series of pictures 20 min scan will be performed at 2 hours after an intravenous injection of a small amount of radioactive traces drug 18F-fluoromisonidazole 18F-FMISO to observe the active hypoxia tumors areas Upon completion of the 18F-FMISO PET scan direct oxygen measurements will be obtained by placing a small needle into the tumor under computer tomographic CT guidance The PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy The measurement obtained by 18F-FMISO PET scanning non-invasive technique and by direct needle measurements invasive technique will be correlated with the eventual treatment outcome for future use
Before beginning radiotherapy a PET scan series of pictures 20 min scan will be performed at 2 hours after an intravenous injection of a small amount of radioactive traces drug 18F-fluoromisonidazole 18F-FMISO to observe the active hypoxia tumors areas Upon completion of the 18F-FMISO PET scan direct oxygen measurements will be obtained by placing a small needle into the tumor under computer tomographic CT guidance The PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy The measurement obtained by 18F-FMISO PET scanning non-invasive technique and by direct needle measurements invasive technique will be correlated with the eventual treatment outcome for future use
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