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NCT Number: NCT07199101

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

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.

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Key information

Conditions

Radiation Dose Reduction

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

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 outcomes

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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jihang Sun, MD

CONTACT

[email protected]

+86 13521158011

Sponsors and collaborators

Lead sponsor

Beijing Children's Hospital

Other

Registry information

Official study title

Development of a Multicenter Low-Dose CT Protocol for Children Based on Low-Dose Simulation Technology and Verification by Clinical Randomized Controlled Trial

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 30, 2025
Registry last updated: Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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