Fluorine F 18 EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Cervical Cancer

Study Overview
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Brief Summary
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RATIONALE: Diagnostic procedures, such as fluorine F 18 EF5 PET/CT imaging, may help find oxygen in tumor cells. It may also help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This trial is studying fluorine F 18 EF5 PET/CT imaging to see how well it works in finding hypoxia in tumor cells of patients with locally advanced or recurrent/metastatic cervical cancer.

Detailed Description
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OBJECTIVES: To determine if the presence and heterogeneity of hypoxia can be detected by fluorine F 18 EF5 binding in tumors during PET/CT imaging in patients with newly diagnosed or recurrent carcinoma of the cervix. To determine if fludeoxyglucose F 18 uptake correlates with fluorine F 18 EF5 uptake. To assess the relationship between fluorine F 18 EF5 uptake and disease-free and overall survival. OUTLINE: Patients are stratified according to disease stage (locally advanced vs recurrent or metastatic disease). Patients receive fluorine F 18 EF5 IV followed by PET/CT imaging from the base of skull to upper thigh at baseline and during radiotherapy or chemotherapy (i.e., at 3-4 weeks after the initiation of radiotherapy or after the 4th, 5th, or 6th course of chemotherapy). Patients also undergo fludeoxyglucose F 18 PET/CT imaging within 7 to 10 days of the second fluorine F 18 EF5 scan. After completion of study treatment, patients are followed up at 30 days and then annually thereafter.

Official Title
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[F18]EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Carcinoma of the Cervix

Conditions
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Cervical Cancer

Intervention / Treatment
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* Radiation: fludeoxyglucose F 18
* Radiation: fluorine F 18 EF5


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of carcinoma of the cervix meeting 1 of the following criteria: Pathologically confirmed, newly diagnosed stage IB-IVA (locally advanced) disease Imaging evidence of recurrent or metastatic disease Measurable disease, defined as ≥ 1 cm on anatomic imaging PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% WBC > 2,000/mm³ Platelet count > 90,000/mm³ Total bilirubin < 2.0 mg/dL Creatinine < 2.0 mg/dL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reactions attributed to Flagyl (metronidazole) No other condition or personal circumstance that, in the judgment of the Investigator, may interfere with the collection of complete, good-quality data PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

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: All subjects<br> | Radiation: fludeoxyglucose F 18<br> <br> Radiation: fluorine F 18 EF5<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship Between Fluorine F 18 EF5 Uptake and Disease-free Survival and Overall Survival | The study was terminated and no data are available to be reported | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer