Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer

Study Overview
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Brief Summary
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The results of previous studies suggest further development of [18F]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans.

Detailed Description
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All patients will undergo normal diagnostic and staging procedures, including a conventional 18F-FDG PET/CT scan for the purpose of RT or surgical planning. In addition to that, an 18F-EF5 PET/CT scan will be performed on a separate day. The patients receive intravenous injection of 250-350 MBq of [18F]EF5. After that, a venous blood sample will be obtained for measurement of plasma radioactivity. A low-dose CT (helical) will be performed for attenuation correction and anatomical reference. After that, a PET scan will be performed (starting at 3 h after injection). The second 18F-EF5 scan will be performed in a similar way 4-7 days after the first scan. A representative histologic sample of primary tumor is pre-condition for study and an effort is made to store part of fresh histologic material in liquid nitrogen for later use in immunohistochemical analysis. Patients are scheduled to undergo preoperative or definitive chemoradiotherapy using current clinical standards after completion of the current protocol. Follow-up information (event-free survival and overall survival) will be gathered.

Official Title
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Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer

Conditions
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Squamous Cell Carcinoma of the Head and Neck

Intervention / Treatment
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* Drug: 18F-EF5
* Procedure: Pretreatment PET/CT-scan (performed two times)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Performance status: Karnofsky score 70 or better or WHO performance status 2 or better Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck Primary tumor diameter as determined clinically or from contrast enhanced CT or T1-weighed MRI scan must be at least 15 mm Patients with nodal neck metastases of head and neck cancer are eligible Mental status: Patients must be able to understand the meaning of the study The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff Patient, if female, must not be pregnant or lactating at the time of the study Exclusion Criteria: Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease. Patient must have no history of previous chemotherapy or biological therapy or RT for treatment of head and neck cancer. Patient must not have an uncontrolled serious infection Patients with organ metastases in liver, bone, brain or lung.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with stage III-IV head and neck cancer<br>18F-EF5 PET/CT scan | Drug: 18F-EF5<br> <br> * Other names: PET/CT static imaging;Procedure: Pretreatment PET/CT-scan (performed two times)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV) | Standardized Uptake Values (SUV) are determined in the acquisition images of the [18F]EF5 studies.The difference between the baseline and second SUV is calculated and Bland-Altman plots are generated to compare the group means | Baseline and 7 days (ie time between the two scans) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-EF5, PET/CT, Reproducibility