NCT00905801终止不适用
CTP (Computed Tomography Perfusion) Imaging of Lung Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Diagnostic yield of tumor perfusion measurements using a contrast assisted computed tomography technique.
研究概览
简要总结
This is an experimental study of the feasibility and efficacy of CT perfusion (CTP) imaging (CT blood flow measurements) in subjects with non-small cell lung cancer.
详细描述
Drug/Device Information
- Contrast
30 cc bolus of a low osmolar, iodinated CT contrast agent, which is FDA approved and used in the clinical CT Imaging procedure.
- Scanner
The 64 row-multidetector row CT unit (LightSpeed VCT, GE Healthcare, Milwaukee, WI) is FDA approved for clinical CT imaging
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient with any stage non-small cell lung cancer (NSCLC) who will undergo imaging with CT of the chest with intravenous contrast as standard of care. Other imaging tests will be performed as clinically indicated.
- •Patient should be receiving, or planning to receive, or have received systemic therapy (chemotherapy and/or novel agents) treatment with or without radiotherapy. Patients should not be receiving adjuvant or postoperative treatment but neoadjuvant treatment is allowed.
- •Histologically or cytologically proven NSCLC.
- •At least one measurable primary or other intrathoracic/supraclavicular lesion ≥ 1 cm, according to Response Evaluation Criteria in Solid Tumors (RECIST); this lesion should be either proven to be malignant by biopsy or be considered malignant based on its evolution on previous imaging studies. A scan within 3-6 months prior to registration can be used as the baseline scan.
- •Age 18 years or older and ability to provide informed consent.
- •Subjects must use medically appropriate contraception if sexually active; women of childbearing potential must not be pregnant or breastfeeding
- •Subjects must have normal renal function to participate. Standard laboratory testing to evaluate renal function will be performed prior to administering IV contrast and will be available as standard of care. Renal impairment is defined as a glomerular filtration rate of less than 60 ml/min/1.73 m2 BSA, derived from the patients' serum creatinine concentration.
排除标准
- •Subjects of reproductive potential, who are sexually active but unwilling and/or unable to use medically appropriate contraception, or women who are pregnant or breastfeeding;
- •Established allergy to iodine containing contrast media
结局指标
主要结局
Diagnostic yield of tumor perfusion measurements using a contrast assisted computed tomography technique.
时间窗: Data collected during one required study visit, and optional second study visit ~6-8 weeks later.
次要结局
- Reproducibility of tumor blood flow estimates derived by CT.(Data collected during one required study visit, and optional second study visit ~6-8 weeks later.)
- Assessment of the association between tumor vascularity responses after two cycles of chemotherapy and subsequent best tumor response according to standard anatomic response evaluation criteria (RECIST).(Data collected during one required study visit, and optional second study visit ~6-8 weeks later.)
- Predictive value of tumor blood flow for patient survival, compared to the predictive power of tumor size determinations.(Data collected during one required study visit, and optional second study visit ~6-8 weeks later; and during SOC follow-up for survival.)
研究者
研究点 (6)
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