Fluorine F 18 EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Cervical Cancer
Recruitment status was: Recruiting
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.
|Cervical Cancer||Radiation: fludeoxyglucose F 18 Radiation: fluorine F 18 EF5||Phase 1|
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||[F18]EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Carcinoma of the Cervix|
- PET imaging of tumor hypoxia, defined by the maximum standard uptake value and by the tumor to muscle ratio
- Toxicity as assessed by NCI CTCAE v3.0
- Relationship between fluorine F 18 EF5 uptake and disease-free survival and overall survival
|Study Start Date:||May 2008|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978874
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892|
|Principal Investigator:||Lilie Lin, MD||Abramson Cancer Center of the University of Pennsylvania|
|OverallOfficial:||Michael Mehler||Abramson Cancer Center of the University of Pennsylvania|