Multicenter Pediatric Low-Dose CT Protocol: Development and Clinical Verification

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-18
SponsorBeijing Children's Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 0-17 years.

Pediatric patients for whom a CT examination is deemed necessary by an attending physician.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Low dose CT

    Radiation

    Participants will undergo a low dose CT adopting the pediatric low-dose CT protocol established based on low dose simulation technique.

Treatment groups

2,650 Participants
are divided into 2 treatment groups
Group A: Routine dose CTNo intervention 0 interventions
Group B: Low dose CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: