CT Examination of the AbdomenNCT06142539
The Impact of Different Scanning Methods and Reconstruction Algorithms on CT Image Quality
An observational study of CT Examination of the Abdomen, run by Wei Li at 1 site in China.
Trial summary
Purpose: To evaluate the image quality of deep learning-based image reconstruction (DLIR) algorithm in unenhanced abdominal low-dose CT (LDCT). Methods: CT images of a phantom were reconstructed with Hybrid iterative reconstruction and deep learning image reconstruction (DLIR). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- CT Examination of the Abdomen
- What is being tested?
- CT Radiation Doses
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2024to May 2025
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Abdominal CT examination
Who may be able to join
- Abdominal CT examination
Who cannot join
- pregnancy and lactation for women unstable breath holding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
uCT960+
Shandong, Jinan Shandong, 250000
((Wei Li[Author]), Dr, 13869190655, lwqfsh@126.com
About this study
Purpose: To evaluate the image quality of deep learning-based image reconstruction (DLIR) algorithm in unenhanced abdominal low-dose CT (LDCT).
Methods: CT images of a phantom were reconstructed with Hybrid iterative reconstruction and deep learning image reconstruction (DLIR). The noise power spectrum (NPS) and task transfer function (TTF) were measured. Two patient groups were included in this study: consecutive patients who underwent unenhanced abdominal standard-dose CT reconstructed with hybrid iterative reconstruction (SDCT group) and consecutive patients who underwent unenhanced abdominal LDCT reconstructed of HIR and DLIR (LDCT group). The CT values, standard deviation (SD), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) of the hepatic parenchyma and paraspinal muscle and abdominal subcutaneous fat were evaluated. Radiologists assessed the subjective image quality and lesion diagnostic confidence using a 5-point Likert scale. Quantitative and qualitative parameters were compared between SDCT and LDCT groups.
- Conditions
- CT Examination of the Abdomen
- Being tested
- CT Radiation Doses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Radiation DosesRadiation
Obtaining Low CT Radiation Doses by Adjusting Dose Levels
| Study group | Role | What they receive |
|---|---|---|
| SDCT group | Not described | |
| LDCT group | Not described Receives: Radiation: CT Radiation Doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of phantom research
Compare the changes in spatial resolution (TTF curve) and noise (NPS curve) between different algorithms
Measured: up to six months
Results of human clinical study
General information of clinical trial personnel Compare the general information of two groups of subjects, such as age, weight（kg）, height（m）, gender, and BMI (kg/m2).
Quantitative image analysis The standard deviation (SD), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) of the hepatic parenchyma and paraspinal muscle were evaluated.
Qualitative image analysis Two radiologists qualitatively assessed the overall image noise and overall image quality depiction.
Measured: up to six months
Secondary outcomes (1)
Patient demographics
Participant demographics: Age (year)/Gender/Body weight (kg) / Body mass index (kg/m2)
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start13 Mar 2024
- Primary completionFeb 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CT Examination of the AbdomenStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Li, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142539
- Sponsor's protocol ID
- WLi
- Status last verified
- Mar 2024
- First submitted
- 7 Nov 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qi H, Cui D, Xu S, Li W, Zeng Q. Image quality assessment of artificial intelligence iterative reconstruction for low dose unenhanced abdomen: comparison with hybrid iterative reconstruction. Abdom Radiol (NY). 2025 Jul;50(7):3353-3362. doi: 10.1007/s00261-024-04760-4. Epub 2024 Dec 21.
PubMed 39707032
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Scanning Methods and Reconstruction Algorithms on CT Image Quality
- ClinicalTrials.gov ID
- NCT06142539
- Acronym / sponsor ID
- WLi
- Conditions
- CT Examination of the Abdomen
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wei LiUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 21 Nov 2023 (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.
Purpose: To evaluate the image quality of deep learning-based image reconstruction (DLIR) algorithm in unenhanced abdominal low-dose CT (LDCT).
Methods: CT images of a phantom were reconstructed with Hybrid iterative reconstruction and deep learning image reconstruction (DLIR). The noise power spectrum (NPS) and task transfer function (TTF) were measured. Two patient groups were included in this study: consecutive patients who underwent unenhanced abdominal standard-dose CT reconstructed with hybrid iterative reconstruction (SDCT group) and consecutive patients who underwent unenhanced abdominal LDCT reconstructed of HIR and DLIR (LDCT group). The CT values, standard deviation (SD), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) of the hepatic parenchyma and paraspinal muscle and abdominal subcutaneous fat were evaluated. Radiologists assessed the subjective image quality and lesion diagnostic confidence using a 5-point Likert scale. Quantitative and qualitative parameters were compared between SDCT and LDCT groups.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDCT group | – | – |
| LDCT group | – | Radiation: CT Radiation Doses |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Abdominal CT examination
Key inclusion criteria (1 listed)
- Abdominal CT examination
Key exclusion criteria (1 listed)
- pregnancy and lactation for women unstable breath holding
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 Radiation DosesObtaining Low CT Radiation Doses by Adjusting Dose Levels | Radiation | LDCT group |
Primary outcome
Results of phantom research
Time frame: up to six months
Compare the changes in spatial resolution (TTF curve) and noise (NPS curve) between different algorithms
Results of human clinical study
Time frame: up to six months
General information of clinical trial personnel Compare the general information of two groups of subjects, such as age, weight（kg）, height（m）, gender, and BMI (kg/m2). Quantitative image analysis The standard deviation (SD), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) of the hepatic parenchyma and paraspinal muscle were evaluated. Qualitative image analysis Two radiologists qualitatively assessed the overall image noise and overall image quality depiction.
1 secondary outcome
Patient demographics
Time frame: up to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 39707032Qi H, Cui D, Xu S, Li W, Zeng Q. Image quality assessment of artificial intelligence iterative reconstruction for low dose unenhanced abdomen: comparison with hybrid iterative reconstruction. Abdom Radiol (NY). 2025 Jul;50(7):3353-3362. doi: 10.1007/s00261-024-04760-4. Epub 2024 Dec 21.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CT Examination of the Abdomen, run by Wei Li 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 1 inclusion and 1 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 15 Mar 2024. 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 ((Wei Li[Author]) (13869190655, lwqfsh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of phantom research (time frame: up to six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06142539, which also lists 1 linked publication.
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 15 Mar 2024.