Validation of 18F-MISO-PET and 18F-FLT-PET

Validation of 18F-MISO-PET and 18F-FLT-PET by Immunohistochemical Assessment of Head and Neck Cancer Resection Specimen

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Procedure: 18F-FLT and 18F-MISO-PET

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • UMC St Radboud, Department of Radiotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Squamous cell carcinoma of the head and neck

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	1 month

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Johannes HA Kaanders, PhD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): May 7, 2015
• Last Update Submitted That Met QC Criteria: May 6, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: PET; head and neck cancer; hypoxia; tumor cell proliferation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Anti-Infective Agents; Antiviral Agents; Alovudine
• Other Study ID Numbers: 100 (Other Identifier: GWU)