NCT05047913进行中（未招募）1 期
Comprehensive Evaluation of Tumor Oxygenation, Metabolism and Blood Supply of High Grade Glioma and Cervical Cancers Using Dynamic FAZA PET and Multiparametric MR
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To correlate the relationship between dynamic MRI (tumor perfusion (DSC) and permeability (DCE)) and dynamic 18F-FAZA PET uptake.
研究概览
简要总结
Primary Objectives To investigate the relationship between dynamic MRI, brain tumor perfusion (DSC) and permeability (DCE), and dynamic 18F-FAZA PET uptake.
Secondary Objectives To investigate the relationship between tumors with greater hypoxia defined by qBOLD and 18F-FAZA PET and pathological features including proportionate necrosis, Ki-67 and IDH mutation status
To investigate the correlation between the hypoxic tumor region delineated using 18F-FAZA PET and qBOLD
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
- All
- 接受健康志愿者
- 否
入选标准
- •Glioma Cohort
- •Adult (> 18 years old) patients with newly diagnosed or recurrent high grade glioma with newly confirmed pathology (within 1 month)
- •Able to provide informed consent
- •No contraindications to MRI with gadolinium contrast or 18F-FAZA PET
- •Cervical Cohort
- •Adult (>18 years old) female with newly diagnosed cervical cancer
- •Able to provide informed consent
- •Receiving surgery, radiotherapy or chemotherapy
- •No contraindication to MRI with gadolinium contrast or 18F-FAZA PET
排除标准
- •Glioma Cohort
- •Prior nephrectomy or planned nephrectomy.
- •Prior brain radiation within 30 days.
- •Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 18F-FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before enrollment after informed consent is obtained. The pregnancy test is part of SOC before imaging.
- •Lactation should be suspended for at least two days following the administration of 18F-FAZA to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman.
- •Subjects with contraindications to the use of 18F-FAZA including confirmed allergy.
- •Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET-MRI scanner, because the findings will probably be compromised in image quality with PET-MRI.
- •Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.
- •Cervical Cohort
- •Prior nephrectomy or planned nephrectomy.
- •Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 18F-FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before enrollment after informed consent is obtained. The pregnancy test is part of SOC before imaging.
- •Lactation should be suspended for at least two days following the administration of 18F-FAZA to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman.
- •Subjects with contraindications to the use of 18F-FAZA including confirmed allergy.
- •Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET-MRI scanner, because the findings will probably be compromised in image quality with PET-MRI and MRI.
- •Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.
研究组 & 干预措施
18F-FTX
Experimental
The radioactive tracer (FAZA)
干预措施: 18F-FTX (Drug)
结局指标
主要结局
To correlate the relationship between dynamic MRI (tumor perfusion (DSC) and permeability (DCE)) and dynamic 18F-FAZA PET uptake.
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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