A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This phase II trial is studying how well PET scans using fluoromisonidazole F 18 and fludeoxyglucose F 18 work in finding oxygen in tumor cells of patients undergoing treatment for newly diagnosed stage 1B, stage II, stage II, or stage IV cervical cancer. Diagnostic procedures using positron emission tomography (PET scan), fluoromisonidazole F 18, and fludeoxyglucose F 18 to find oxygen in tumor cells may help doctors predict how patients will respond to treatment.
详细描述
PRIMARY OBJECTIVES:
I. Test the extent to which fluoromisonidazole F 18 ([^18F] FMISO) uptake predicts survival of patients undergoing therapy for newly diagnosed stage IB-IVB cervical cancer.
SECONDARY OBJECTIVES:
I. Test [^18F] FMISO tumor uptake as an independent predictor of response to therapy and that it provides additional predictive power over fludeoxyglucose F 18 ([^18F] FDG).
II. Test [^18F] FMISO tumor uptake as a predictor of response in a subgroup of patients receiving radiotherapy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed squamous cell or adenocarcinoma of the uterine cervix
- •Clinical stage IB-IVB by FIGO criteria
- •Size of the primary tumor ≥ 2 cm as assessed by CT scan
- •Measurable disease
- •Scheduled to undergo radiotherapy, chemotherapy, or combined multimodality management
- •No prior cervical cancer diagnosis
- •No known brain metastases
- •ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
- •Life expectancy > 12 months
- •Not pregnant
- •No nursing for 24 hours after fluoromisonidazole F 18 ([^18F] FMISO) PET scanning
- •Negative pregnancy test
- •Weight ≤ 400 lbs
- •Sufficiently healthy to undergo cancer treatment
- •Willing to undergo PET scanning with urinary bladder catheterization
- •Leukocytes ≥ 3,000/mm³
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Total bilirubin normal
- •AST/ALT ≤ 2.5 times normal
- •Creatinine normal OR creatinine clearance ≥ 60 mL/min
- •No serious medical co-morbidities that would preclude definitive local therapy
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to [^18F] FMISO
- •No concurrent uncontrolled illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness/social situations that would limit compliance with study requirements.
- •No prior surgery or radiotherapy for cervical cancer
- •Other concurrent investigational agents allowed
排除标准
- 未提供
研究组 & 干预措施
Diagnostic FMISO AND FDG PET
Patients receive ^18F FMISO IV over 1 minute followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
干预措施: fluorodeoxyglucose F 18 (Radiation)
Diagnostic FMISO AND FDG PET
Patients receive ^18F FMISO IV over 1 minute followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
干预措施: positron emission tomography (Procedure)
Diagnostic FMISO AND FDG PET
Patients receive ^18F FMISO IV over 1 minute followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
干预措施: tissue oxygen measurement (Other)
Diagnostic FMISO AND FDG PET
Patients receive ^18F FMISO IV over 1 minute followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
干预措施: 18F-fluoromisonidazole (Other)
结局指标
主要结局
Overall Survival (OS)
时间窗: For up to 2 years
Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.
Disease-free Survival (DFS)
时间窗: Up to 2 years
Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.
次要结局
- Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor(Up to 2 years)
- Relationship Between Ki67 and Regional FMISO Uptake in Tumor(Up to 2 years)
- Response to XRT Using RECIST(time to disease progression or 2 years following first FMISO scan)