Cathartic-Free Dual Energy Computerized Tomography (DECT) Colonography.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Clinical performance of dual-energy CT colonography (CTC).
研究概览
简要总结
Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or larger without cathartic preparation.
详细描述
Determine the feasibility to differentiate polyps from stool with or without the use of contrast agents and to assess the feasibility and accuracy of dual energy techniques in a pilot patient study.
1.1 Formulate algorithms that use dual-energy information to quantitatively measure specific material density of colon polyps in physics based simulation.
1.2 Determine optimal scanning parameters on prototype CT equipment.
2.1 Measure the material composition density and Hounsfield number of polyps with and without simulated contrast enhancement.
2.2 Measure the accuracy of dual-energy techniques to differentiate between polyps and stool and if needed using a combination of simulated intravenous enhanced polyps and contrast material tagged stool.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a known colorectal polyp or colon carcinoma with pathology, at or greater than 1 cm in size on a colonoscopy that is completed either eight weeks before or after CT Colonography study visit.
- •If receiving iodine oral or IV contrast, must have a creatinine less than 1.4 on record within last 30 days of study visit date. If no creatinine is available, one will be drawn for enrollment criteria purposes.
排除标准
- •Pregnant females.
- •Presence of colostomy or right hemicolectomy.
- •Inflammatory bowel disease (Crohn's, chronic ulcerative colitis).
- •Familial polyposis syndrome.
- •Pregnant female.
- •Creatinine at or greater than 1.4
- •Severe or uncontrolled chronic obstructive pulmonary disease (COPD) or chronic obstructive lung disease (COLD).
- •Iodine contrast allergy.
结局指标
主要结局
Clinical performance of dual-energy CT colonography (CTC).
时间窗: Three Months
Detection of polyps in cathartic-free CTC using optimized dual-energy techniques.
次要结局
未报告次要终点