Radiation Dose Reduction
Conditions
Keywords
Tomography, X-ray computed, Child, radiation dose
Brief 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 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
RADIATIONLow dose CT
Participants will undergo a low dose CT adopting the pediatric low-dose CT protocol established based on low dose simulation technique.
Sponsors
Beijing Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From enrollment to the end of treatment at 12 weeks | 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. |
Countries
China
Contacts
Primary ContactJihang Sun, MD
Outcome results
None listed