Multicenter Pediatric Low-Dose CT Protocol: Development and Clinical Verification
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low dose CT.
- Who it may be relevant to
- Registry conditions: Radiation Dose Reduction. Basic parameters: 0 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Radiation Low dose CT
Participants will undergo a low dose CT adopting the pediatric low-dose CT protocol established based on low dose simulation technique.
Primary outcome measures
- 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]
Secondary outcome measures (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. [Time frame: From enrollment to the end of treatment at 12 weeks]
Eligibility criteria
Inclusion criteria
- Aged 0-17 years.
- Pediatric patients for whom a CT examination is deemed necessary by an attending physician.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Diagnostic
Study locations
China · 20 centers
- Beijing Children's Hospital, Capital Medical University, National Center for Children's He — Beijing
- Beijing Friendship Hospital, Capital Medical University — Beijing
- Beijing Tongren Hospital, Capital Medical University — Beijing
- Medical Center for Capital Children's Health, Capital Medical University — Beijing
- National Institute for Radiological Protection, China CDC — Beijing
- Peking Union Medical College Hospital — Beijing
- Children's Hospital of Chongqing Medical University, National Clinical Research Center for — Chongqing
- Guangdong Women and Children Hospital — Guangzhou
- … and 12 more centers
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. PMID 37672054
- Bosch 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 PMID 37946058
Identifiers
NCT: NCT07199101 · 2025-Y-131-D · YGSKL-SHTech-2025-KF01