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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Radiation Dose Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

On the RCT trial procedure, Participants will be randomly assigned to the intervention group (adopting the pediatric low-dose CT protocol established based on LDS) or the conventional CT dose group (adopting China's pediatric CT Diagnostic Reference Level protocol) at a 1:1 ratio. A statistician who is not directly involved in the analysis of study results or image evaluation will develop independent randomization schemes for each participating center using the randomized block design, so as to further reduce inter-center bias and ensure the concealment of the allocation scheme.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Routine dose CT

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Low dose CT

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

Group Type EXPERIMENTAL

Low dose CT

Intervention Type RADIATION

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

Interventions

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Low dose CT

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

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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