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| Sponsor: | Radboud University |
|---|---|
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00159978 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Neoplasms |
Procedure: 18F-FLT and 18F-MISO-PET |
Phase I |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Validation of 18F-MISO-PET and 18F-FLT-PET by Immunohistochemical Assessment of Head and Neck Cancer Resection Specimen |
Tumor resection specimen
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Squamous cell carcinoma of the head and neck
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Esther GC Troost, MD | +31-24-3614505 | e.troost@rther.umcn.nl |
| Contact: Johannes HA Kaanders, PhD | +31-24-3614505 | j.kaanders@rther.umcn.nl |
| Netherlands, Gelderland | |
| UMC St Radboud, Department of Radiotherapy | Recruiting |
| Nijmegen, Gelderland, Netherlands, 6500 HB | |
| Contact: Esther GC Troost, MD +31-24-3614505 e.troost@rther.umcn.nl | |
| Contact: Johannes HA Kaanders, PhD +31-24-3614505 j.kaanders@rther.umcn.nl | |
| Principal Investigator: Johannes HA Kaanders, PhD | |
| Principal Investigator: | Johannes HA Kaanders, PhD | Radboud University |
More Information
| Responsible Party: | Radboud University Medical Centre ( Prof. J. Kaanders ) |
| Study ID Numbers: | 100 |
| Study First Received: | September 9, 2005 |
| Last Updated: | November 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00159978 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
head and neck cancer hypoxia tumor cell proliferation PET |
|
Neoplasms Neoplasms by Site Head and Neck Neoplasms |
