[F18]EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Carcinoma of the Cervix
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Relationship Between Fluorine F 18 EF5 Uptake and Disease-free Survival and Overall Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
All subjects
干预措施: fluorine F 18 EF5 (Radiation)
All subjects
干预措施: fludeoxyglucose F 18 (Radiation)
结局指标
主要结局
Relationship Between Fluorine F 18 EF5 Uptake and Disease-free Survival and Overall Survival
时间窗: 7 years
The study was terminated and no data are available to be reported
次要结局
未报告次要终点