Colorectal Polyps Screening With Low-dose CT Colonoscopy

NCT ID: NCT03064828

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-12-31

Brief Summary

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

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:

1. 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.

2. 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.

Conditions

Polyps; Colorectal Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

CT colonoscopy(normal dose)

Intervention Type: 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

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

Group Type: EXPERIMENTAL

CT colonoscopy (low dose)

Intervention Type: 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

Interventions

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 kVp, 100-200mA

Intervention Type: 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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shuhui Liang, MD

Role: STUDY_DIRECTOR

Air Force Military Medical University, China

Jiang Meng, MS

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Xiaofeng Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Hong Yin, MD

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Hainan Sang, MS

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Locations

Xi jing Hospital

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shuhui Liang, MD

Role: CONTACT

liangsh@fmmu.edu.cn

Facility Contacts

Liang Shuhui, MD

Role: primary

Other Identifiers

KY20162082-1

Identifier Type: -

Identifier Source: org_study_id