Validation of 18F-MISO-PET and 18F-FLT-PET - Full Text View

Sponsored by:	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:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Validation of 18F-MISO-PET and 18F-FLT-PET by Immunohistochemical Assessment of Head and Neck Cancer Resection Specimen

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy Surgery

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:

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 Measures:

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.

Estimated Enrollment:	50
Study Start Date:	July 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159978

Contacts

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

Locations

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

Sponsors and Collaborators

Radboud University

Investigators

Principal Investigator:

Johannes HA Kaanders, PhD

Radboud University

More Information

No publications provided

Study ID Numbers:	100
Study First Received:	September 9, 2005
Last Updated:	June 21, 2006
ClinicalTrials.gov Identifier:	NCT00159978 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

head and neck cancer
hypoxia
tumor cell proliferation
PET

Study placed in the following topic categories:

Head and Neck Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on July 06, 2009