Colorectal Adenoma Screening by Low-dose CT Colonoscopy With Computer-aided Detection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of low-dose CTC for the polyp detection
研究概览
简要总结
This preliminary clinical trial aims to evaluate the performance of the low-dose CT colonoscopy (CTC) with computer aided detection (CAD) on polyps detection compared with optical colonoscopy (OC), and explore the possible clinical routine for integrated use of CT colonoscopy and optical colonoscopy OC in colorectal cancer screening.
详细描述
CT colonoscopy (CTC), also referred to as virtual colonoscopy (VC), utilizes computer virtual-reality techniques to navigate inside a three-dimensional patient-specific colon model reconstructed from abdominal CT images, looking for colonic lesions, full bowel preparation and colon inflation are needed to perform CTC examination. The clinical trial consists of two major parts:
- Comparative study on the performance of CTC and OC: 50 subjects will be recruited in this part with written consents. With full bowel preparation, all the volunteers receive CT scans first with inflated colon, then OC followed by the same day, and necessary pathological analysis thereafter. The performance of CTC based on high-resolution CT data, including the number of polyps detected, size, position, etc, will be validated by that of OC with the paired comparison.
- Integrate use of low-dose CTC with OC for colorectal cancer screening: After the validation of CTC performance, in this part, another 50 subjects will be recruited to explore the integrated use of CTC with OC as a possible and efficient workflow for colorectal cancer screening. In this part, a combination of normal dose and low-dose scan protocols will be employed (e.g., normal dose on supine, low-dose on prone), low-dose CTC based on the low-dose CT scanning protocol and an artifacts reduction technique will be introduced to reduce the radiation risk in screening.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with gastrointestinal symptoms potentially suggestive of colorectal cancer, such as diarrhea, constipation, abdominal pain or discomfort, rectal bleeding, iron-deficiency anemia, and unintended weight loss.
- •Subjects with pathological confirmed colorectal cancer or polyps that need follow-up examination.
- •Subjects with written consents
排除标准
- •Subjects with acute colitis
- •Acute diverticulitis
- •Inguinal hernia including colon
- •Colorectal surgery or endoscopic biopsy or resection of polyps within 6 months
- •Known or suspected as colon perforated
- •Complete intestinal obstruction
- •Pregnant or lactating women
研究组 & 干预措施
CT colonoscopy(normal dose)
Perform CT colonoscopy with full bowel preparation and inflated colon, CT Scans on subjects with normal-dose protocol by setting scanning parameters as 120-140 kilovolts peak (kVp), 100-200mA
干预措施: CT colonoscopy(normal dose) (Radiation)
CT colonoscopy(low dose)
Perform CT colonoscopy with full bowel preparation and inflated colon, CT Scans on subjects with normal-dose protocol by setting scanning parameters as 120-140 kVp, 20-100mA
干预措施: CT colonoscopy (low dose) (Radiation)
结局指标
主要结局
Sensitivity and specificity of low-dose CTC for the polyp detection
时间窗: within the first 30 days (plus or minus 3 days) after the completion of the first part of the trial
return the number of polyps detected by low-dose CTC for each participant, sensitivity and specificity of low-dose CTC for the polyp detection can be derive from it with OC results as reference.
次要结局
- CT radiation(within the first 3 days after each examination.)
- Sensitivity and specificity of CTC for the detection of polyps with different shapes(within the first 30 days after the completion of the trial.)
- Sensitivity and specificity of CTC for the detection of poly malignancy(within the first 30 days after the completion of the trial.)