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

Abramson Cancer Center at Penn Medicine

Status

Terminated

Conditions

Cervical Cancer

Treatments

Radiation: fludeoxyglucose F 18

Radiation: fluorine F 18 EF5

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00978874

UPCC 03808

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: