An interventional study of Low dose CT in Radiation Dose Reduction, sponsored by Beijing Children's Hospital. Not yet recruiting at 20 sites in China. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by Beijing Children's Hospital · Not applicable, Interventional, and Diagnostic
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.
Beijing Children's Hospital is the lead sponsor of 51 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will undergo a routine dose CT adopting China's pediatric CT Diagnostic Reference Level protocol
Participants will undergo a low dose CT adopting the pediatric low-dose CT protocol established based on LDS
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.
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.
Time frame: From enrollment to the end of treatment at 12 weeks
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.
Time frame: From enrollment to the end of treatment at 12 weeks
Plan to share: Undecided
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Beijing Children's Hospital