Fluorine F 18 EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00978874|
Recruitment Status : Unknown
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : September 17, 2009
Last Update Posted : October 20, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Radiation: fludeoxyglucose F 18 Radiation: fluorine F 18 EF5||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Masking:||None (Open Label)|
|Official Title:||[F18]EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Carcinoma of the Cervix|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||May 2010|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|