Clinical trial NCT03064828: Colorectal Polyps Screening With Low-dose CT Colonoscopy
Official title: Colorectal Adenoma Screening by Low-dose CT Colonoscopy With Computer-aided Detection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polyps
Colorectal Neoplasm
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
First posted: 2017-02-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Sensitivity and specificity of low-dose CTC for the polyp detection
timeFrame: within the first 30 days (plus or minus 3 days) after the completion of the first part of the trial
Secondary outcomes:
measure: CT radiation
timeFrame: within the first 3 days after each examination.
measure: Sensitivity and specificity of CTC for the detection of polyps with different shapes
timeFrame: within the first 30 days after the completion of the trial.
measure: Sensitivity and specificity of CTC for the detection of poly malignancy
timeFrame: within the first 30 days after the completion of the trial.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi jing Hospital
state: Shan XI
Study officials:
affiliation: Air Force Military Medical University, China
name: Shuhui Liang, MD
role: STUDY_DIRECTOR
affiliation: Air Force Military Medical University, China
name: Jiang Meng, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Air Force Military Medical University, China
name: Xiaofeng Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Air Force Military Medical University, China
name: Hong Yin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Air Force Military Medical University, China
name: Hainan Sang, MS
role: PRINCIPAL_INVESTIGATOR
References: