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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00978874
• Other study ID #: UPCC 03808
• Status: Terminated
• Phase: N/A
• Start date: May 2008
• Est. completion date: September 4, 2013

Study information

• Verified date: June 2021
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 4, 2013
• Est. primary completion date: September 4, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• fludeoxyglucose F 18

• fluorine F 18 EF5

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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