Radiation Dose ReductionNCT07199101
Multicenter Pediatric Low-Dose CT Protocol: Development and Clinical Verification
A study testing Low dose CT in people with Radiation Dose Reduction, run by Beijing Children's Hospital at 20 sites in China.
Trial summary
Children are sensitive to ionizing radiation, and there are significant regional variations in current pediatric CT radiation doses. Although there are studies on low-dose CT targeting single lesions, these studies require clear clinical indications and support from advanced equipment, making widespread promotion… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Radiation Dose Reduction
- What is being tested?
- Low dose CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,650 participants
- Where
- 20 sitesChina
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 0-17 years.
- Pediatric patients for whom a CT examination is deemed necessary by an attending physician.
Who cannot join
- Parents/guardians refuse to consent to low-dose CT examination.
- Pediatric patients are in critical condition, with no time allocated for explanation of the randomized controlled trial (RCT) protocol.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
China20 sites
Baoding Hospital, Beijing Children's Hospital Affiliated to Capital Medical University
Baoding, Heibei
Lili Zang, MD, +86 15203220998, 1374190373@qq.com
Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
Beijing, Beijing Municipality
Jihang Sun, MD, +86 13521158011, jihangsuns@163.com
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Yantao Niu, PhD, +86 13693664085, ytniu163@163.com
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
Dandan Liu, PhD, +86 13701124170, trdandan4170@163.com
Medical Center for Capital Children's Health, Capital Medical University
Beijing, Beijing Municipality
National Institute for Radiological Protection, China CDC
Beijing, Beijing Municipality
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Wei Liu, MD, +86 13261960902, lwpumch@163.com
Children's Hospital of Changchun
Changchun, Jilin
the First Hospital of Jilin University
Changchun, Jilin
Jing Wang, MD, +86 15804300153, wangj66@jlu.edu.cn
Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders.
Chongqing, Chongqing Municipality
Ling He, MD, +86 13983399138, 480056@hospital.cqmu.edu.cn
Guangdong Women and Children Hospital
Guangzhou, Guangdong
Zhiqiu Ye, MD, +86 13688898540, ye0542@sina.cn
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Ge Wen, MD, +86 13360022166, 1113470826@qq.com
Shanghai Children's Medical Center, School of Medicine
Shanghai, Shanghai Municipality
Yumin Zhong, MD, +86 18930830851, zyumin2002@163.com
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Dengbin Wang, MD, +86 13916656531, dbwang8@aliyun.com
ShanghaiTech University
Shanghai, Shanghai Municipality
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang
Yan Wang, MD, +86 13699982055, drwangxj@163.com
Affiliated Women's Hospital of Jiangnan University
Wuxi, Jiangsu
Xinkai Zhao, MD, +86 15861600014, zxk_kk@163.com
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi
Jian Yang, MD, +86 18191975783, yj1118@mail.xjtu.edu.cn
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan
Yinghui Ge, MD, +86 13603989332, cjr.geyinghui@vip.163.com
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Xin Zhao, MD, +86 13676939116, zdsfyzx@zzu.edu.cn
About this study
Official title: Development of a Multicenter Low-Dose CT Protocol for Children Based on Low-Dose Simulation Technology and Verification by Clinical Randomized Controlled Trial
Children are sensitive to ionizing radiation, and there are significant regional variations in current pediatric CT radiation doses. Although there are studies on low-dose CT targeting single lesions, these studies require clear clinical indications and support from advanced equipment, making widespread promotion difficult. The establishment of low-dose CT protocols is mostly experience-based; when radiologists lack confidence in image quality, the credibility of diagnostic reports is compromised. Therefore, the development of low-dose protocols must meet the diagnostic confidence of most radiologists, enable clear visualization of key anatomical structures in clinical practice, and satisfy the requirements for disease diagnosis.
The purpose of this study is to establish a pediatric low-dose CT scanning protocol using Low-dose Simulation of CT (LDS) technology, and conduct a multicenter randomized controlled trial (RCT) in clinical settings to verify the clinical feasibility of this low-dose CT scanning protocol.
- Conditions
- Radiation Dose Reduction
- Being tested
- Low dose CT
- Keywords
- Tomography, X-ray computed, Child, radiation dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose CTRadiation
Participants will undergo a low dose CT adopting the pediatric low-dose CT protocol established based on low dose simulation technique.
| Study group | Role | What they receive |
|---|---|---|
| Routine dose CT | No intervention | Participants will undergo a routine dose CT adopting China's pediatric CT Diagnostic Reference Level protocol |
| Low dose CT | Experimental | Participants will undergo a low dose CT adopting the pediatric low-dose CT protocol established based on LDS Receives: Radiation: Low dose CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the diagnostic performance of CT findings, including the concordance rate with pathological gold standards, other imaging modalities (e.g., MRI), or clinical diagnoses.
With the clinical diagnosis (finally confirmed in pediatric patients after consultation, based on pathology, laboratory tests, other imaging examinations, and clinical characteristics) as the gold standard, determine the concordance rate between CT findings and clinical diagnoses.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (1)
To assess discrepancies in subjective image quality ratings among observers, using the Multi-Rater Concordance Correlation (MCRC) statistical method to evaluate the consistency of ratings across different observers.
To analyze differences in diagnostic confidence in images among observers with different years of experience. For CT diagnostic reports showing insufficient diagnostic confidence, the specific criterion is the frequency of descriptive terms indicating low confidence (e.g., "possible," "further examination required," "follow-up review recommended") in the reports.
To compare differences in radiation doses (CTDI in mSv) between two CT protocols with different dose settings.
To calculate the radiation dose (CTDI in mSv) difference between the two protocols based on radiation dose data from dose reports.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radiation Dose ReductionStudies 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
- Model description
- On the RCT trial procedure, Participants will be randomly assigned to the intervention group (adopting the pediatric low-dose CT protocol established based on LDS) or the conventional CT dose group (adopting China's pediatric CT Diagnostic Reference Level protocol) at a 1:1 ratio. A statistician who is not directly involved in the analysis of study results or image evaluation will develop independent randomization schemes for each participating center using the randomized block design, so as to further reduce inter-center bias and ensure the concealment of the allocation scheme.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199101
- Sponsor's protocol ID
- 2025-Y-131-D
- Other IDs
- YGSKL-SHTech-2025-KF01
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu H, Sun QF, Yue BR, Cheng JS, Niu YT. Results and analysis of examination doses for paediatric CT procedures based on a nationwide survey in China. Eur Radiol. 2024 Mar;34(3):1659-1666. doi: 10.1007/s00330-023-10005-7. Epub 2023 Sep 6.
PubMed 37672054Bosch de Basea M, Thierry-Chef I, Harbron R, Hauptmann M, Byrnes G, Bernier MO, Le Cornet L, Dabin J, Ferro G, Istad TS, Jahnen A, Lee C, Maccia C, Malchair F, Olerud H, Simon SL, Figuerola J, Peiro A, Engels H, Johansen C, Blettner M, Kaijser M, Kjaerheim K, Berrington de Gonzalez A, Journy N, Meulepas JM, Moissonnier M, Nordenskjold A, Pokora R, Ronckers C, Schuz J, Kesminiene A, Cardis E. Risk of hematological malignancies from CT radiation exposure in children, adolescents and young adults. Nat Med. 2023 Dec;29(12):3111-3119. doi: 10.1038/s41591-023-02620-0. Epub 2023 Nov 9.
PubMed 37946058
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Multicenter Low-Dose CT Protocol for Children Based on Low-Dose Simulation Technology and Verification by Clinical Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07199101
- Acronym / sponsor ID
- 2025-Y-131-D
- Conditions
- Radiation Dose Reduction
- Keywords
- Tomography, X-ray computed, Child, radiation dose
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,650 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Sep 2025 (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.
Children are sensitive to ionizing radiation, and there are significant regional variations in current pediatric CT radiation doses. Although there are studies on low-dose CT targeting single lesions, these studies require clear clinical indications and support from advanced equipment, making widespread promotion difficult. The establishment of low-dose CT protocols is mostly experience-based; when radiologists lack confidence in image quality, the credibility of diagnostic reports is compromised. Therefore, the development of low-dose protocols must meet the diagnostic confidence of most radiologists, enable clear visualization of key anatomical structures in clinical practice, and satisfy the requirements for disease diagnosis.
The purpose of this study is to establish a pediatric low-dose CT scanning protocol using Low-dose Simulation of CT (LDS) technology, and conduct a multicenter randomized controlled trial (RCT) in clinical settings to verify the clinical feasibility of this low-dose CT scanning protocol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- On the RCT trial procedure, Participants will be randomly assigned to the intervention group (adopting the pediatric low-dose CT protocol established based on LDS) or the conventional CT dose group (adopting China's pediatric CT Diagnostic Reference Level protocol) at a 1:1 ratio. A statistician who is not directly involved in the analysis of study results or image evaluation will develop independent randomization schemes for each participating center using the randomized block design, so as to further reduce inter-center bias and ensure the concealment of the allocation scheme.
| Arm | Type | Receives |
|---|---|---|
| Routine dose CT | No intervention | –Participants will undergo a routine dose CT adopting China's pediatric CT Diagnostic Reference Level protocol |
| Low dose CT | Experimental | Radiation: Low dose CTParticipants will undergo a low dose CT adopting the pediatric low-dose CT protocol established based on LDS |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Aged 0-17 years.
- Pediatric patients for whom a CT examination is deemed necessary by an attending physician.
Key exclusion criteria (2 listed)
- Parents/guardians refuse to consent to low-dose CT examination.
- Pediatric patients are in critical condition, with no time allocated for explanation of the randomized controlled trial (RCT) protocol.
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 |
|---|---|---|
| Low dose CTParticipants will undergo a low dose CT adopting the pediatric low-dose CT protocol established based on low dose simulation technique. | Radiation | Low dose CT |
Primary outcome
To evaluate the diagnostic performance of CT findings, including the concordance rate with pathological gold standards, other imaging modalities (e.g., MRI), or clinical diagnoses.
Time frame: From enrollment to the end of treatment at 12 weeks
With the clinical diagnosis (finally confirmed in pediatric patients after consultation, based on pathology, laboratory tests, other imaging examinations, and clinical characteristics) as the gold standard, determine the concordance rate between CT findings and clinical diagnoses.
1 secondary outcome
To assess discrepancies in subjective image quality ratings among observers, using the Multi-Rater Concordance Correlation (MCRC) statistical method to evaluate the consistency of ratings across different observers.
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Results publication: PubMed 37672054Xu H, Sun QF, Yue BR, Cheng JS, Niu YT. Results and analysis of examination doses for paediatric CT procedures based on a nationwide survey in China. Eur Radiol. 2024 Mar;34(3):1659-1666. doi: 10.1007/s00330-023-10005-7. Epub 2023 Sep 6.
- Results publication: PubMed 37946058Bosch de Basea M, Thierry-Chef I, Harbron R, Hauptmann M, Byrnes G, Bernier MO, Le Cornet L, Dabin J, Ferro G, Istad TS, Jahnen A, Lee C, Maccia C, Malchair F, Olerud H, Simon SL, Figuerola J, Peiro A, Engels H, Johansen C, Blettner M, Kaijser M, Kjaerheim K, Berrington de Gonzalez A, Journy N, Meulepas JM, Moissonnier M, Nordenskjold A, Pokora R, Ronckers C, Schuz J, Kesminiene A, Cardis E. Risk of hematological malignancies from CT radiation exposure in children, adolescents and young adults. Nat Med. 2023 Dec;29(12):3111-3119. doi: 10.1038/s41591-023-02620-0. Epub 2023 Nov 9.
- 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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose CT in people with Radiation Dose Reduction, run by Beijing Children's Hospital at 20 sites 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihang Sun, MD (+86 13521158011, jihangsuns@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the diagnostic performance of CT findings, including the concordance rate with pathological gold standards, other imaging modalities (e.g., MRI), or clinical diagnoses. (time frame: From enrollment to the end of treatment at 12 weeks). 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 NCT07199101, which also lists 2 linked publications.
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 30 Sep 2025.