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

NCT ID: NCT00159978

Last Updated: 2015-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johannes HA Kaanders, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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UMC St Radboud, Department of Radiotherapy

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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100

Identifier Type: -

Identifier Source: org_study_id

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