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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 9, 2005 | ||||||||
| Last Updated Date | August 17, 2009 | ||||||||
| Start Date ICMJE | July 2005 | ||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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. | ||||||||
| Change History | Complete list of historical versions of study NCT00159978 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
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. | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Validation of 18F-MISO-PET and 18F-FLT-PET | ||||||||
| Official Title ICMJE | Validation of 18F-MISO-PET and 18F-FLT-PET by Immunohistochemical Assessment of Head and Neck Cancer Resection Specimen | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Prospective | ||||||||
| Condition ICMJE | Head and Neck Neoplasms | ||||||||
| Intervention ICMJE | Procedure: 18F-FLT and 18F-MISO-PET | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | July 2011 | ||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00159978 | ||||||||
| Responsible Party | Prof. J. Kaanders, Radboud University Medical Centre | ||||||||
| Study ID Numbers ICMJE | 100 | ||||||||
| Study Sponsor ICMJE | Radboud University | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Radboud University | ||||||||
| Verification Date | May 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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