Validation of 18F-MISO-PET and 18F-FLT-PET
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Validation of 18F-MISO-PET and 18F-FLT-PET by Immunohistochemical Assessment of Head and Neck Cancer Resection Specimen|
- To validate 18F-MISO-PET for detection of tumor hypoxia and 18F-FLT-PET for detection of tumor cell proliferation by immunohistochemical assessment of hypoxia and proliferation in head and neck cancer resection specimen. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- To assess if functional information obtained by 18F-MISO-PET and 18F-FLT-PET can improve the definition of target volume for radiotherapy treatment planning. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Tumor resection specimen
|Study Start Date:||July 2005|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Procedure: 18F-FLT and 18F-MISO-PET
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159978
|Contact: Esther GC Troost, MDfirstname.lastname@example.org|
|Contact: Johannes HA Kaanders, PhDemail@example.com|
|UMC St Radboud, Department of Radiotherapy||Recruiting|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Contact: Esther GC Troost, MD +31-24-3614505 firstname.lastname@example.org|
|Contact: Johannes HA Kaanders, PhD +31-24-3614505 email@example.com|
|Principal Investigator: Johannes HA Kaanders, PhD|
|Principal Investigator:||Johannes HA Kaanders, PhD||Radboud University|