Colorectal Polyps Screening With Low-dose CT Colonoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Colorectal Adenoma Screening by Low-dose CT Colonoscopy With Computer-aided Detection

Conditions
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Polyps, Colorectal Neoplasm

Intervention / Treatment
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* Radiation: CT colonoscopy(normal dose)
* Radiation: CT colonoscopy (low dose)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CT colonoscopy(normal dose)<br>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 | Radiation: CT colonoscopy(normal dose)<br>* 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<br>|
| Experimental: CT colonoscopy(low dose)<br>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 | Radiation: CT colonoscopy (low dose)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |