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

This study is currently recruiting participants.
Verified December 2011 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00159978
First received: September 9, 2005
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  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:

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. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tumor resection specimen


Estimated Enrollment: 50
Study Start Date: July 2005
Estimated Study Completion Date: December 2013
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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
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

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00159978     History of Changes
Other Study ID Numbers: 100
Study First Received: September 9, 2005
Last Updated: December 15, 2011
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

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Alovudine
 Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013