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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
2,650
Participants will undergo a low dose CT adopting the pediatric low-dose CT protocol established based on low dose simulation technique.
Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Medical Center for Capital Children's Health, Capital Medical University
Beijing, Beijing Municipality, China
National Institute for Radiological Protection, China CDC
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
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, China
Guangdong Women and Children Hospital
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Baoding Hospital, Beijing Children's Hospital Affiliated to Capital Medical University
Baoding, Heibei, China
...and 10 more locations
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
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