CT Metrology: Quantitative Imaging Metrics With Advanced Visualization Tools for Cancer Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Agreement between QIM predicted and clinically observed perioperative measurements such as blood loss, operative time, and eGFR
研究概览
简要总结
This pilot research trial studies quantitative imaging metrics derived from contrast enhanced computed tomography (CECT) in enhancing assessment of disease status in patients with kidney cancer. Quantitative imaging is the extraction of quantifiable features from radiological images for the assessment of disease status. Collecting quantitative imaging metrics from CECT imaging may help doctors predict tumor aggressiveness and nuclear grade (tumor stage) and assess treatment response and prognosis in cancer imaging.
详细描述
PRIMARY OBJECTIVES:
I. To investigate the role of quantitative imaging metrics (QIM) as a potential DIAGNOSTIC biomarker.
II. To investigate if QIM parameters can differentiate clear cell renal cell carcinoma (RCC) from papillary RCC.
III. To evaluate the tumor grade of the target lesion as assessed by QIM from CECT for agreement with the pathological (Fuhrman) grade.
IV. To investigate the role of QIM as a potential PROGNOSTIC biomarker. V. To develop a novel method of calculating renal tumor contact surface area (CSA) using advanced image-processing technology (MATLAB®, 3 dimension [D] Synapse) and predict peri-operative variables such as blood loss, operative time and post-operative estimated glomerular filtration rate (eGFR) in patients undergoing partial nephrectomy (PN).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subjects with a renal mass who are scheduled for surgery for presumed RCC
- •Subjects scheduled for standard of care contrast enhanced CT examination at USC Norris Comprehensive Cancer Center
- •Subjects competent to sign study specific written informed consent
排除标准
- •Subjects who are pregnant
- •Subjects who cannot consent for themselves
结局指标
主要结局
Agreement between QIM predicted and clinically observed perioperative measurements such as blood loss, operative time, and eGFR
时间窗: Baseline
Examined using two-way random single measure with absolute agreement.
Agreement between QIM predicted and pathologically determined tumor (Fuhrman) grade
时间窗: Baseline
Examined using weighted kappa coefficient.
Agreement between QIM predicted and pathologically determined tumor class (clear cell renal cell carcinoma [ccRCC] vs papillary [p]RCC)
时间窗: Baseline
Cohen's kappa coefficient will be used to examine the agreement between QIM predicted and pathologically determined tumor class (ccRCC vs. pRCC).
Agreement between QIM predicted and clinical determined postoperative eGFR
时间窗: Baseline
Examined using two-way random single measure with absolute agreement.
次要结局
未报告次要终点