Colorectal Polyps Screening With Low-dose CT Colonoscopy

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

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.

Study Overview

• Status: Unknown
• Conditions: Polyps; Colorectal Neoplasm
• Intervention / Treatment: Radiation: CT colonoscopy(normal dose); Radiation: CT colonoscopy (low dose)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shan XI
    • Xi'an, Shan XI, China, 710032
      • Recruiting
      • Xi jing Hospital
      • Contact: Liang Shuhui, MD
      • Principal Investigator: Sang Hainan, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Radiation: 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
EXPERIMENTAL: 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	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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Air Force Military Medical University, China
• Investigators: Study Director: Shuhui Liang, MD, Air Force Military Medical University, China; Principal Investigator: Jiang Meng, MS, Air Force Military Medical University, China; Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (ACTUAL): February 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Polyps
• Other Study ID Numbers: KY20162082-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED