Evaluation of Accuracy of Computed Tomographic Colonography (CTC) in the Diagnosis of Colorectal Tumors by Gastroenterologists and Radiologists With Computer-aided Detection (CAD): A Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,257
- 试验地点
- 24
- 主要终点
- sensitivity in the detection of colorectal polyps and cancers in CTC
研究概览
简要总结
The purpose of this study is to evaluate the sensitivity of computed tomographic colonography (CTC) in detecting colorectal polyps and cancers in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard.
详细描述
The investigators will evaluate the sensitivity of CTC in detecting colorectal polyps and cancers (at least 6 mm in diameter) in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard. The primary endpoint will be sensitivity in the detection of colorectal polyps and cancers that are at least 6 mm in diameter. The secondary endpoints will include specificity and predictive values in the detection of colorectal polyps and cancers.
This clinical study will also evaluate the differences of the detection accuracies between human readings with and without computer-aided detection (CAD) that automatically detects colonic lesions in CTC images and presents the detected lesions to the readers. This clinical study will also compare performance between radiologists and gastroenterologists in detecting colorectal lesions in CTC images.
All the CTC images and their interpretations, optical colonoscopy reports and images, and pathology reports of resected colorectal lesion will be prospectively collected from 12 Japanese hospitals participating in the trial. All patients' information will be completely anonymized at each site before any analysis of the data takes place.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients who are eligible for optical colonoscopy.
- •Aged 20 years or older.
- •Major functions of organs of the subjects are in a good condition.
- •Signed informed consent forms are obtained from the patients.
排除标准
- •Known colorectal polyps or cancers at any site at the time of enrollment.
- •Patients with inflammatory bowel disease.
- •Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria).
- •Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit.
- •Previous colorectal surgery.
- •Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
- •Evidence of an increased risk in carrying out bowel preparation or CTC exams.
- •Possibility of pregnancy.
- •Optical colonoscopy or barium enema carried out within the last 3 years.
- •Patients with psychological conditions that contraindicate colonoscopy or that make them irrelevant to participate in the trial.
- •Iodine hypersensitivity.
- •Severe thyroid disease.
- •Claustrophobia.
- •Severe deafness.
- •Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
结局指标
主要结局
sensitivity in the detection of colorectal polyps and cancers in CTC
时间窗: 1.5 years
次要结局
- specificity and predictive values in the detection of colorectal polyps and cancers in CTC.(1.5 years)
研究者
Hiroyuki Yoshida
3D Imaging Laboratory, Massachusetts General Hospital
Japanese CT Colonography Society