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

Not Applicable
Terminated
Conditions
Cervical Cancer
Interventions
Radiation: fludeoxyglucose F 18
Radiation: fluorine F 18 EF5
Registration Number
NCT00978874
Lead Sponsor
Abramson Cancer Center at Penn Medicine
Brief Summary

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

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
15
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
All subjectsfludeoxyglucose F 18-
All subjectsfluorine F 18 EF5-
Primary Outcome Measures
NameTimeMethod
Relationship Between Fluorine F 18 EF5 Uptake and Disease-free Survival and Overall Survival7 years

The study was terminated and no data are available to be reported

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

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