Clinical trial NCT00978874: Fluorine F 18 EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Cervical Cancer
Official title: [F18]EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Carcinoma of the Cervix
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Cancer
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
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-09-17
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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:

* Not specified

Primary outcomes:
measure: Relationship Between Fluorine F 18 EF5 Uptake and Disease-free Survival and Overall Survival
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Lilie Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: