Fluorine F 18 EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Cervical Cancer
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
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
Study Type
Study Phase
Phase 1
Study Design
Masking: Open Label, Primary Purpose: Diagnostic
Name: fludeoxyglucose F 18 Type: Radiation
Name: fluorine F 18 EF5 Type: Radiation
Overall Status
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 phase I 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

- 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female

- 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


- 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


- Not specified
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers - 800-474-9892
Start Date
May 2008
Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page