PolypsNCT03064828
Colorectal Polyps Screening With Low-dose CT Colonoscopy
A study testing CT colonoscopy(normal dose) and CT colonoscopy (low dose) in people with Polyps and Colorectal Neoplasm, run by Xijing Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyps, Colorectal Neoplasm
- What is being tested?
- CT colonoscopy(normal dose) and CT colonoscopy (low dose)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Shuhui Liang, MD contact
China1 site, 1 recruiting
- Recruiting
Xi jing Hospital
Xi'an, Shaanxi, 710032
Liang Shuhui, MD
Sang Hainan, MS
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Polyps, Colorectal Neoplasm
- Being tested
- CT colonoscopy(normal dose), CT colonoscopy (low dose)
- Medical subject headings
- Polyps, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: CT colonoscopy(normal dose) |
| 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 Receives: Radiation: CT colonoscopy (low dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 30 days (plus or minus 3 days) after the completion of the first part of the trial
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: within the first 30 days after the completion of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Responsible party
- Sponsor
- Investigators
- Shuhui Liang, MD, Study director, Air Force Military Medical University, ChinaJiang Meng, MS, Principal investigator, Air Force Military Medical University, ChinaXiaofeng Zhang, MD, Principal investigator, Air Force Military Medical University, ChinaHong Yin, MD, Principal investigator, Air Force Military Medical University, ChinaHainan Sang, MS, Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064828
- Sponsor's protocol ID
- KY20162082-1
- Status last verified
- Nov 2017
- First submitted
- 24 Jan 2017
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Adenoma Screening by Low-dose CT Colonoscopy With Computer-aided Detection
- ClinicalTrials.gov ID
- NCT03064828
- Acronym / sponsor ID
- KY20162082-1
- Conditions
- Polyps, Colorectal Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT colonoscopy(normal dose) | Active comparator | 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 kilovolts peak (kVp), 100-200mA |
| CT colonoscopy(low dose) | Experimental | 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Radiation | CT colonoscopy(normal dose) |
| 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) |
Primary outcome
Sensitivity and specificity of low-dose CTC for the polyp detection
Time frame: within the first 30 days (plus or minus 3 days) after the completion of the first part of the trial
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.
3 secondary outcomes
CT radiation
Time frame: within the first 3 days after each examination.
Sensitivity and specificity of CTC for the detection of polyps with different shapes
Time frame: within the first 30 days after the completion of the trial.
Sensitivity and specificity of CTC for the detection of poly malignancy
Time frame: within the first 30 days after the completion of the trial.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuhui Liang, MD contact
Shuhui Liang, MD study director
Air Force Military Medical University, China
Jiang Meng, MS principal investigator
Air Force Military Medical University, China
Xiaofeng Zhang, MD principal investigator
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT colonoscopy(normal dose) and CT colonoscopy (low dose) in people with Polyps and Colorectal Neoplasm, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuhui Liang, MD (liangsh@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of low-dose CTC for the polyp detection (time frame: within the first 30 days (plus or minus 3 days) after the completion of the first part of the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.