Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159978
Status:
TERMINATED
Last Update Posted:
2015-05-07
First Post:
2005-09-09
Brief Title:
Validation of 18F-MISO-PET and 18F-FLT-PET
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Validation of 18F-MISO-PET and 18F-FLT-PET by Immunohistochemical Assessment of Head and Neck Cancer Resection Specimen
Status:
TERMINATED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Problems with FMISO supply
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypoxia and tumor cell proliferation are important mechanisms contributing to resistance to radiotherapy in human head and neck tumor cells Currently assessment of these two tumor characteristics is performed in biopsies using immunohistochemical staining and subsequent analysis A promising non-invasive method of characterizing a tumor is the use of positron-emission tomography PET Specific tracers can be used to detect hypoxia and proliferative activity 18F-misonidazole is a tracer for hypoxia and 18F-thymidine is a tracer for proliferation
Patients suffering from head and neck cancer and who will undergo surgery will be included in this study
One week before the surgery the patients will undergo a CT-scan and a PET-scan with either of the tracers Shortly before the surgery they will be given immunohistochemically detectable marker substances enabling the characterization of the tumor samples gathered from the resection specimen These markers are pimonidazole for detection of hypoxia and iododeoxyuridine for detection of tumor cell proliferation
The data collected by PET-scan will be analysed and compared to the results acquired by immunohistochemistry
Patients suffering from head and neck cancer and who will undergo surgery will be included in this study
One week before the surgery the patients will undergo a CT-scan and a PET-scan with either of the tracers Shortly before the surgery they will be given immunohistochemically detectable marker substances enabling the characterization of the tumor samples gathered from the resection specimen These markers are pimonidazole for detection of hypoxia and iododeoxyuridine for detection of tumor cell proliferation
The data collected by PET-scan will be analysed and compared to the results acquired by immunohistochemistry
Detailed Description:
None
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