Validation of 18F-MISO-PET and 18F-FLT-PET
Information source: Radboud University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Neoplasms
Intervention: 18F-FLT and 18F-MISO-PET (Procedure)
Phase: Phase 1
Status: Recruiting
Sponsored by: Radboud University Official(s) and/or principal investigator(s):
Johannes HA Kaanders, PhD, Principal Investigator, Affiliation: Radboud University
Overall contact:
Esther GC Troost, MD, Phone: +31-24-3614505, Email: e.troost@rther.umcn.nl
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.
Clinical Details
Official title: Validation of 18F-MISO-PET and 18F-FLT-PET by Immunohistochemical Assessment of Head and Neck Cancer Resection Specimen
Study design: Cohort, Prospective
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Stage II-IV squamous cell carcinoma of the oral cavity, oropharynx, larynx or
hypopharynx, planned for curative resection.
- Age >18 years.
- Written informed consent.
Exclusion Criteria:
- Pregnancy.
- Prior treatment for this tumor
- Women breast feeding
Locations and Contacts
Esther GC Troost, MD, Phone: +31-24-3614505, Email: e.troost@rther.umcn.nl
UMC St Radboud, Department of Radiotherapy, Nijmegen, Gelderland 6500 HB, Netherlands; Recruiting
Esther GC Troost, MD, Phone: +31-24-3614505, Email: e.troost@rther.umcn.nl
Johannes HA Kaanders, PhD, Phone: +31-24-3614505, Email: j.kaanders@rther.umcn.nl
Johannes HA Kaanders, PhD, Principal Investigator
Additional Information
Starting date: July 2005
Ending date: July 2011
Last updated: August 17, 2009
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