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| Name | Class |
|---|---|
| Air Force Military Medical University, China | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT colonoscopy(normal dose) | Active Comparator | 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 |
|
| CT colonoscopy(low dose) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT colonoscopy(normal dose) | Radiation | 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, 100-200mA |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of low-dose CTC for the polyp detection | 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. | within the first 30 days (plus or minus 3 days) after the completion of the first part of the trial |
| Measure | Description | Time Frame |
|---|---|---|
| CT radiation | Record the dose-length product of each CT scan for CTC participants and radiation dose of each scan can be derived from it. | within the first 3 days after each examination. |
| Sensitivity and specificity of CTC for the detection of polyps with different shapes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuhui Liang, MD | Contact | liangsh@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shuhui Liang, MD | Air Force Military Medical University, China | Study Director |
| Jiang Meng, MS | Air Force Military Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xi jing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D011127 | Polyps |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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| CT colonoscopy (low dose) | Radiation | 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 |
|
Return the shape and location information of polyps detected by OC and CTC for each participant to reflect the CTC performance for the detection of polyps with different morphologies, especially for three major morphologic categories: sessile, pedunculated, and flat. |
| within the first 30 days after the completion of the trial. |
| Sensitivity and specificity of CTC for the detection of poly malignancy | Return the histological types of polyps biopsied through OC after pathologic examination to reflect the CTC performance for the detection of polyp malignancy, especially the capability to differentiate adenomatous polyps from hyperplastic polyps. | within the first 30 days after the completion of the trial. |
| Xiaofeng Zhang, MD |
| Air Force Military Medical University, China |
| Principal Investigator |
| Hong Yin, MD | Air Force Military Medical University, China | Principal Investigator |
| Hainan Sang, MS | Air Force Military Medical University, China | Principal Investigator |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |