Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
21 participants
OBSERVATIONAL
2005-07-31
2013-12-31
Brief Summary
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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
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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18F-FLT and 18F-MISO-PET
18F-FLT-PET-images will be acquired one hour after injection of 250 MBq FLT. 18F-MISO-PET: 400 MBq FMISO will be injected intravenously. Marker administration: The day before surgery (≤ 24h) pimonidazole (500 mg/m2) will be administered intravenously in 100 ml saline over 20 min. IdUrd (200 mg) will be administered as bolus injection 20 min before surgery.
Eligibility Criteria
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Inclusion Criteria
* Age \>18 years.
* Written informed consent.
Exclusion Criteria
* Prior treatment for this tumor
* Women breast feeding
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Johannes HA Kaanders, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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UMC St Radboud, Department of Radiotherapy
Nijmegen, Gelderland, Netherlands
Countries
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Other Identifiers
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100
Identifier Type: -
Identifier Source: org_study_id
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