Prospective Comparison of Ultra-Low-Dose Versus Standard-Dose Computed Tomography for Esophageal Foreign Body Detection

Summary

This randomized trial demonstrates that ultra-low-dose computed tomography (CT) with deep learning reconstruction achieves diagnostic accuracy non-inferior to that of standard-dose CT for esophageal foreign body detection, with a 63% reduction in radiation dose.

Abstract

The objective of this study was to verify the non-inferiority of ultra-low-dose computed tomography (ULD-CT) versus standard-dose CT (SD-CT) for esophageal foreign body (EFB) detection and to quantify dose-quality trade-offs. This prospective, randomized, blinded-reader study enrolled 180 patients (120 adults, 60 children) presenting with suspected EFB ingestion. Patients were randomized to ULD-CT (100 kV/50 mA, adaptive statistical iterative reconstruction-V 80% + deep learning image reconstruction) or SD-CT (120 kV/200 mA, filtered back projection + adaptive statistical iterative reconstruction-V 30%) groups. All patients underwent endoscopic or surgical reference-standard evaluation within 12 h of CT imaging, with 30-day follow-up for negative findings. The primary endpoint was the area under the curve (AUC); secondary endpoints included image quality metrics, radiation dose, and incidental findings.

Both protocols achieved excellent diagnostic performance, with sensitivity/specificity of 97.8%/100% for ULD-CT and 98.9%/100% for SD-CT. The AUC was 0.985 for ULD-CT versus 0.991 for SD-CT (difference < non-inferiority margin). The effective dose was reduced by 63% with ULD-CT (P < 0.001). The signal-to-noise ratio decreased by 37% (P < 0.001), yet diagnostic acceptability (score ≥3) was maintained at 94.4% versus 97.8% (P = 0.070). Incidental findings were identified in 54 patients (30.0%), including 19 potentially actionable findings (10.6%) and 6 high-significance findings requiring urgent evaluation.

Ultra-low-dose CT demonstrates non-inferior diagnostic accuracy compared with SD-CT for EFB detection while reducing radiation exposure by over 60%. These findings show potential for ULD-CT as a first-line modality for suspected EFBs pending multicenter validation.

Introduction

Foreign body ingestion remains a common emergency presentation worldwide, with esophageal foreign bodies (EFBs) accounting for a clinically important subset that often requires urgent imaging or endoscopic intervention^1,2,3. Recent radiology reviews emphasize that CT is particularly valuable when radiographs are negative, the object is radiolucent, or complications such as perforation are suspected^1,2. Special patient populations, including individuals with intellectual disabilities or impaired communication, may pres....

Protocol

This prospective, randomized, blinded-reader study was conducted at a tertiary care center (The First Hospital of Hebei Medical University) between January 2024 and June 2025. This study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of The First Hospital of Hebei Medical University (Approval Number: [2025]YS-062), and all patients or their legal guardians provided written informed consent prior to enrollment. For minors, informed consent was obtained according to age and capacity: for participants under 8 years of age, written informed consent was obtained from their legal guardians, with additional assent sought fro....

Results

Patient demographics and scan parameters
Between January 2024 and June 2025, 198 patients were assessed for eligibility (Supplementary Figure 1). Eighteen patients were excluded (8 due to immediate surgical indications, 6 with BMI > 40 kg/m², and 4 who declined consent), leaving 180 patients randomized equally to the SD-CT and ULD-CT protocols. All patients completed their assigned CT protocol and reference standard evaluation. Table 1 summ.......

Discussion

This prospective randomized trial demonstrates that ULD-CT with DLIR achieves diagnostic accuracy that is non-inferior to that of SD-CT for EFB detection while reducing radiation exposure by 63%. The maintained detection of clinically significant incidental findings suggests that dose reduction need not compromise this important secondary benefit, supporting the potential for ULD-CT as a primary imaging strategy for suspected EFBs across adult and pediatric populations. The success of dramatic dose reduction while mainta.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Advantage Workstation (AW) 4.7	GE Healthcare	https://www.gehealthcare.com/en-us/products/imaging-applications/advanced-visualization-applications/advantage-workstation	Imaging workstation
ASiR-V (Adaptive Statistical Iterative Reconstruction-V)	GE Healthcare	N/A	Adaptive statistical iterative reconstruction
AW Server 3.2 Ext 4.0	GE Healthcare	https://www.gehealthcare.com/en-us/products/advanced-visualization-platforms/aw-server	CT system software
Centricity Universal Viewer 6.0	GE Healthcare	https://www.gehealthcare.com/en-us/products/software/enterprise-imaging/centricity-universal-viewer	PACS viewer
MedCalc version 20.0 (MedCalc Software; RRID:SCR_015044)	MedCalc Software	Version 20.0	Medical statistics
Organ Dose Modulation	GE Healthcare	N/A	Organ-based tube current modulation
pROC package for R	CRAN Repository	Version 1.18.4	ROC curve analysis
R version 4.3.2 (R Foundation for Statistical Computing)	R Foundation	RRID:SCR_001905	Statistical computing
Revolution CT (256-slice)	GE Healthcare	https://www.gehealthcare.com/en-us/products/computed-tomography/revolution	CT scanner
Smart mA	GE Healthcare	N/A	Automatic tube current modulation
Standard kernel (soft tissue)	GE Healthcare	N/A	Reconstruction kernel
TrueFidelity DLIR (Deep Learning Image Reconstruction), Medium strength	GE Healthcare	https://www.gehealthcare.com/en-us/products/computed-tomography/applications/true-fidelity	Deep learning image reconstruction