NCT07199101|Not Yet RecruitingDMC

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

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

Beijing Children's Hospital ClinicalTrials.gov

Compare

2 other identifiers

2025-Y-131-DYGSKL-SHTech-2025-KF01

Study Type

interventional

Target

2,650

Locations

1 country

Sites

Timeline

RegisteredSep 2025

StartedJan 2026

CompletionDec 2027

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,650

participants targeted

Target at P75+ for not_applicable

Timeline

20mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach

1 country

20 active sites

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Progress17%

Jan 2026Dec 2027

First Submitted

Initial submission to the registry

September 18, 2025

Completed

12 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed

3 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 18, 2025

Last Update Submit

September 22, 2025

Conditions

Radiation Dose Reduction

Keywords

Tomography, X-ray computedChildradiation dose

Outcome Measures

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.
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.
From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Routine dose CT

NO INTERVENTION

Participants will undergo a routine dose CT adopting China's pediatric CT Diagnostic Reference Level protocol

Low dose CT

EXPERIMENTAL

Participants will undergo a low dose CT adopting the pediatric low-dose CT protocol established based on LDS

Radiation: Low dose CT

Interventions

Low dose CTRADIATION

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

Low dose CT

Eligibility Criteria

Age0 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Aged 0-17 years.
Pediatric patients for whom a CT examination is deemed necessary by an attending physician.

You may not qualify if:

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.

Contact the study team to confirm eligibility.