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

This study has been terminated.
(Problems with FMISO supply)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00159978
First Posted: September 12, 2005
Last Update Posted: May 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Radboud University
  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 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:


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. [ Time Frame: 1 month ]

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. [ Time Frame: 1 month ]

Biospecimen Retention:   Samples With DNA
Tumor resection specimen

Enrollment: 21
Study Start Date: July 2005
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Squamous cell carcinoma of the head and neck
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159978


Locations
Netherlands
UMC St Radboud, Department of Radiotherapy
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Johannes HA Kaanders, PhD Radboud University
  More Information

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00159978     History of Changes
Other Study ID Numbers: 100
First Submitted: September 9, 2005
First Posted: September 12, 2005
Last Update Posted: May 7, 2015
Last Verified: May 2015

Keywords provided by Radboud University:
head and neck cancer
hypoxia
tumor cell proliferation
PET

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Alovudine
Misonidazole
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents