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Research Article

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

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DOI:

10.3791/69349

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August 7th, 2026

 ,  ,  ,  ,  ,  ,  ,  , 
1Department of Radiology and Nuclear Medicine, The First Hospital of Hebei Medical University

* These authors contributed equally

In This Article

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 intervention1,2,3. Recent radiology reviews emphasize that CT is particularly valuable when radiographs are negative, the object is radiolucent, or complications such as perforation are suspected1,2. Special patient populations, including individuals with intellectual disabilities or impaired communication, may present late or with atypical symptoms and may ingest non-food, sharp-edged, or multiple objects, creating additional diagnostic and management challenges4. Recent hospital-based studies from China further show that sharp foreign bodies and food impactions remain common causes of EFB presentation in adults and older patients, although nationwide incidence data are still lacking5,6.

Despite the clinical importance of accurate EFB detection, major knowledge gaps remain regarding optimal imaging strategies. Current protocols typically employ standard radiation doses developed for general thoracic imaging rather than indication-specific parameters optimized for foreign body conspicuity, while dose-reduction guidance emphasizes tailoring exposure to the diagnostic task7. Furthermore, although iterative reconstruction and deep learning reconstruction have enabled marked radiation reductions in other CT applications, their impact on EFB detection has not been systematically evaluated in prospective randomized trials8.

Traditional imaging evaluation of suspected EFBs has relied on plain radiography followed by selective contrast esophagography or endoscopy for radiolucent objects1,3,9. However, computed tomography (CT) has increasingly emerged as the preferred modality due to its superior sensitivity for both radiopaque and radiolucent foreign bodies. Studies have demonstrated that CT sensitivity approaches 100% compared with 70%–80% for plain radiographs, particularly for fishbones and other low-density materials10,11. The cross-sectional nature of CT also provides crucial information about complications, including perforation, abscess formation, and vascular proximity, that may alter patient management12,13.

The widespread adoption of CT has raised concerns about cumulative radiation exposure, particularly in pediatric populations, in which lifetime cancer risk from medical imaging is highest14,15. Traditional CT protocols deliver effective doses of 8–12 mSv for chest examinations, prompting the development of dose reduction strategies aligned with the "as low as reasonably achievable" principle and modern CT dose-management recommendations7,16.

Recent technological advances have enabled dramatic dose reductions while maintaining diagnostic quality. Iterative reconstruction algorithms such as adaptive statistical iterative reconstruction reduce image noise compared with filtered back projection, allowing lower radiation doses17. The newest generation of deep learning image reconstruction (DLIR) algorithms leverage convolutional neural networks trained on high-quality datasets to distinguish signal from noise, achieving superior noise reduction to conventional iterative techniques8,18. Studies have demonstrated that DLIR can maintain diagnostic image quality at radiation doses substantially lower than those used in standard protocols19,20.

Despite the promise of ultra-low-dose CT (ULD-CT) protocols, their application specifically for EFB detection remains unexplored in prospective randomized trials. Previous studies of low-dose chest CT have focused on lung nodule detection or general thoracic pathology rather than the unique diagnostic requirements of foreign body evaluation21,22. Additionally, the impact of dose reduction on the detection of clinically relevant incidental findings—a potential added value of CT imaging—has not been systematically evaluated in this context23.

This study aimed to address these knowledge gaps by conducting a prospective comparison of ULD-CT and standard-dose CT (SD-CT) for EFB detection. We hypothesized that (1) ULD-CT would demonstrate non-inferiority to SD-CT for diagnostic accuracy (non-inferiority margin δ = 5%); (2) the radiation dose would be substantially reduced while maintaining acceptable image quality; and (3) the broader field-of-view advantage of CT would enable detection of clinically relevant incidental findings that could impact patient management beyond the presenting complaint.

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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 from the child when capable of understanding; for participants aged 8–17 years, written informed consent was obtained from both the minor and their legal guardian, with information disclosed at an age-appropriate level; participants aged 16–17 years who demonstrated financial independence through their own labor income were considered to have full civil capacity and could provide independent consent. The study has been registered with the UK Clinical Study Registry, registration number ISRCTN13588740.

Study design
Patient randomization was performed using a computer-generated sequence with permuted blocks of varying sizes (4, 6, and 8) stratified by age group (pediatric < 18 years vs. adult ≥ 18 years). Allocation concealment was maintained through sealed opaque envelopes opened immediately prior to CT scanning. All image interpreters, endoscopists, and surgeons were blinded to the CT protocol assignment.

Study population
Inclusion criteria
Eligible participants were patients aged 3–80 years presenting to the emergency department and referred for CT evaluation based on institutional protocols (primarily for suspected radiolucent foreign bodies not visible on plain radiography, clinical suspicion of complications, or need for precise localization prior to intervention), with (1) a history of foreign body ingestion within 6 hours of presentation; (2) symptoms suggestive of esophageal impaction, including dysphagia, odynophagia, chest pain, or hypersalivation; and (3) planned endoscopic or surgical evaluation within 12 h of CT imaging. The 6 h window was selected to ensure patients represented acute presentations while allowing sufficient time for imaging and endoscopic evaluation, though this may limit generalizability to delayed presentations common with certain foreign body types, such as fishbones.

Exclusion criteria
Patients were excluded if they had (1) severe cardiorespiratory instability requiring immediate intervention; (2) pregnancy or a positive pregnancy test; (3) a known contrast allergy (for enhanced scans when clinically indicated); (4) prior esophageal surgery or known esophageal stricture; (5) metallic implants causing substantial artifacts affecting >30% of the esophageal evaluation area; and (6) body mass index (BMI) > 40 kg/m2 (due to potential image quality degradation at ultra-low doses).

Computed tomography scanning protocols
All examinations were performed on 256-slice multi-detector CT scanners with deep-learning reconstruction capabilities. Patients were positioned supine with their arms elevated above their heads when possible. No oral contrast was administered to avoid obscuring foreign bodies or delaying endoscopy.

The SD-CT protocol utilized parameters consistent with the routine chest CT protocol at our institution: a tube voltage of 120 kV, a reference tube current of 200 mA with automatic tube current modulation (ATCM) enabled, a rotation time of 0.5 s, a pitch of 0.992, and collimation of 0.625 mm. Images were reconstructed using filtered back projection with 30% adaptive statistical iterative reconstruction blending, representing the current clinical standard at the participating site. The rationale for 120 kV was based on standard thoracic imaging protocols optimized for general diagnostic purposes.

The ULD-CT protocol employed aggressive dose reduction strategies: a tube voltage of 100 kV, a reference tube current of 50 mA with ATCM (range 10–80 mA), and an identical rotation time and pitch to that of the SD protocol. The 100 kV/50 mA parameters were selected based on preliminary phantom studies demonstrating maintained foreign body conspicuity at these settings when combined with advanced reconstruction. Raw data were reconstructed using 80% adaptive statistical iterative reconstruction blending, followed by DLIR at medium strength. This dual-reconstruction approach maximized noise reduction while preserving anatomical detail and avoiding the plastic appearance sometimes associated with aggressive iterative reconstruction alone.

For both protocols, images were reconstructed at a 0.625 mm slice thickness with a 0.5 mm overlap to enable multiplanar reformations. The scan range extended from the lower neck (C3 level) through the gastroesophageal junction, with careful positioning to minimize breast tissue inclusion in female patients. Dose reduction features, including organ-based tube current modulation and adaptive collimation, were enabled for all scans.

Data collection and variables
Patient characteristics
Demographic and clinical data collected included age, sex, BMI, presenting symptoms, time from ingestion to imaging, type of foreign body reported by history, relevant comorbidities (diabetes mellitus, chronic obstructive pulmonary disease, prior thoracic malignancy), and prior CT examinations within 6 months.

Foreign body characteristics
For confirmed EFB cases, the following were documented: (1) material composition (bone, metal, food bolus, plastic, other); (2) maximum dimension measured on CT; (3) attenuation in Hounsfield units (HU) measured using a standardized 5 mm2 region of interest; (4) anatomical location using established landmarks (cervical C3–C7, upper thoracic T1–T4, mid-thoracic T5–T8, lower thoracic T9–T12); and (5) the presence of complications, including perforation, pneumomediastinum, or abscess formation.

Image quality assessment
Objective image quality metrics were measured by a medical physicist blinded to the protocol assignment. The signal-to-noise ratio (SNR) was calculated as the mean attenuation of the descending aorta divided by the standard deviation of subcutaneous fat. The contrast-to-noise ratio was calculated as the difference in attenuation between aortic blood and paraspinal muscle divided by image noise. To better align with the diagnostic task, additional measurements were performed in the paraesophageal fat. Measurements were performed on axial images at three standardized levels (aortic arch, carina, and mid-esophagus) with circular regions of interest (150 mm2) placed consistently using anatomical landmarks.

Subjective image quality was independently assessed by two thoracic radiologists with 8 years and 12 years of experience. Images were reviewed on diagnostic workstations using standardized soft-tissue and lung window settings (window width: 350 HU, window level: 40 HU for soft tissue; window width: 1,500 HU, window level: -600 HU for lung evaluation), consistent with routine thoracic CT interpretation and artifact-recognition principles24. Readers scored the following parameters on a 5-point Likert scale: (1) edge definition of the mediastinal structures; (2) image noise; (3) diagnostic confidence for foreign body detection; and (4) overall diagnostic quality. A score ≥3 was considered diagnostically acceptable. Discrepancies between readers were resolved through consensus review, with the consensus score used for analysis. Inter-reader agreement was assessed using weighted kappa statistics.

Radiation dose metrics
The scanner-reported volume CT dose index (CTDIvol) and dose-length product were recorded for each examination. The effective dose (ED) was calculated using age- and sex-specific conversion factors (k = 0.014 mSv·mGy⁻1·cm⁻1 for adults; age-adjusted factors for pediatric patients) based on International Commission on Radiological Protection Publication 103 recommendations25. Size-specific dose estimates were calculated using patient anteroposterior and lateral dimensions measured at the mid-chest level.

Reference standard
The reference standard for foreign body presence and location was established through endoscopic visualization or surgical findings performed within 12 h of CT imaging for all randomized patients, irrespective of CT protocol assignment or CT result. Endoscopy reports were reviewed by two gastroenterologists to confirm the foreign body characteristics and anatomical location using standardized landmarks. When endoscopy or surgery did not identify a retained foreign body, clinical follow-up at 30 days through a chart review and telephone contact confirmed the absence of missed foreign bodies, with specific inquiry about return visits, delayed complications, or the need for repeat imaging or endoscopy. A uniform reference-standard application was used to minimize differential verification bias.

Incidental findings
All CT examinations were systematically reviewed for incidental findings unrelated to the indication for imaging by the same two radiologists who performed the quality assessment. The findings were categorized by anatomical location (pulmonary, mediastinal, cardiovascular, upper abdominal, osseous, other) and clinical significance. Clinical significance was classified as follows: (1) low—findings requiring no follow-up (e.g., simple hepatic cysts, degenerative spine changes); (2) moderate—findings potentially requiring follow-up imaging (e.g., thyroid nodules > 1 cm, indeterminate adrenal nodules); (3) high—findings requiring urgent evaluation or intervention (e.g., suspicious pulmonary nodules, aortic aneurysm > 5 cm, suspicious breast masses). Age and sex distributions of the incidental findings were recorded, and downstream management pathways were documented for all actionable findings.

Statistical analysis
Sample size calculation
Sample size was calculated based on the primary endpoint of diagnostic accuracy (the area under the curve; AUC). Assuming a standard-dose AUC of 0.97 based on the literature and an expected ULD-CT AUC of 0.95, a 5-percentage-point non-inferiority margin was selected a priori because an AUC loss greater than 0.05 would be clinically meaningful enough to alter imaging triage, whereas a smaller reduction was considered acceptable when balanced against substantial radiation reduction and mandatory endoscopic or surgical confirmation. Using a one-sided alpha of 0.025, 80% power, independent patient groups, and ROC-based sample size assumptions for diagnostic accuracy studies26, 166 patients were required. Accounting for an 8% dropout rate or technical failure, the target enrollment was 180 patients.

Primary analysis
The primary analysis compared the area under the receiver operating characteristic (ROC) curve between ULD-CT and SD-CT for foreign body detection. Non-inferiority was declared if the lower bound of the 95% confidence interval (CI) for the AUC difference (ULD-CT minus SD-CT) exceeded -0.05, and ROC curves were constructed using radiologist confidence scores (1–5 scale) as the diagnostic variable. Because this was a parallel-arm design with independent patient groups, the DeLong method for independent ROC-curve comparison was used for statistical testing27. Reader scores were averaged when both readers provided assessments, and this average was used as the diagnostic variable for ROC analysis. Sensitivity and specificity denominators represent reference-standard positive and reference-standard negative diagnostic decision units, respectively, rather than the total number of randomized participants in each protocol arm.

Secondary analyses
Given the parallel-arm randomized design, all comparative analyses used independent-sample methods. Continuous variables (dose metrics, image quality scores) were compared between protocols using independent-sample t-tests or Mann-Whitney U tests based on distribution normality assessed by Shapiro-Wilk testing. Categorical variables were compared using chi-square tests or Fisher's exact tests for unpaired proportions. Sensitivity, specificity, and accuracy were compared using Wald CIs and chi-square tests for independent samples. Inter-reader agreement was assessed using weighted kappa statistics with quadratic weights within each protocol arm separately.

Subgroup analyses examined diagnostic performance stratified by (1) age group (pediatric vs. adult); (2) foreign body density (high > 100 vs. low ≤ 100 HU); (3) BMI categories (<25, 25–30, >30 kg/m2); and (4) anatomical location (cervical vs. thoracic esophagus). Interaction terms were formally tested using logistic regression models.

Multivariable logistic regression identified predictors of missed or indeterminate foreign bodies, with candidate variables including foreign body size, density, anatomical location, patient BMI, image noise (SNR), and reconstruction algorithm. Interaction terms for protocol × density and protocol × BMI were included based on a priori hypotheses. Model selection used backward elimination with a retention threshold of P < 0.10.

For incidental findings, because patients were randomized to different protocols and did not undergo both scans, sensitivity and agreement calculations across protocols were not appropriate and were removed from the analysis. Instead, we compared the prevalence and distribution of incidental findings between protocols using chi-square tests.

Contrast-enhanced examinations (performed in 23 patients in the SD-CT arm and 21 patients in the ULD-CT arm based on a clinical indication for vascular or mediastinal evaluation) were analyzed separately to assess the influence on diagnostic confidence and incidental finding detection.

All analyses followed intention-to-treat principles. Missing data (<2% overall) were handled using multiple imputation with 10 imputed datasets. Statistical analyses were performed using R version 4.3.2 and MedCalc version 20.0. Two-sided P-values < 0.05 were considered statistically significant except in the primary non-inferiority analysis.

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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...

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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...

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Disclosures

None of the authors has any personal, financial, commercial, or academic conflicts of interest.

Acknowledgements

The study was conducted with funding from the Hebei Province Medical Science Research Key Project (No. 20180252).

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Materials

List of materials used in this article
NameCompanyCatalog NumberComments
Advantage Workstation (AW) 4.7GE Healthcarehttps://www.gehealthcare.com/en-us/products/imaging-applications/advanced-visualization-applications/advantage-workstationImaging workstation
ASiR-V (Adaptive Statistical Iterative Reconstruction-V)GE HealthcareN/AAdaptive statistical iterative reconstruction
AW Server 3.2 Ext 4.0GE Healthcarehttps://www.gehealthcare.com/en-us/products/advanced-visualization-platforms/aw-serverCT system software
Centricity Universal Viewer 6.0GE Healthcarehttps://www.gehealthcare.com/en-us/products/software/enterprise-imaging/centricity-universal-viewerPACS viewer
MedCalc version 20.0 (MedCalc Software; RRID:SCR_015044)MedCalc SoftwareVersion 20.0Medical statistics
Organ Dose ModulationGE HealthcareN/AOrgan-based tube current modulation
pROC package for RCRAN RepositoryVersion 1.18.4ROC curve analysis
R version 4.3.2 (R Foundation for Statistical Computing)R FoundationRRID:SCR_001905Statistical computing
Revolution CT (256-slice)GE Healthcarehttps://www.gehealthcare.com/en-us/products/computed-tomography/revolutionCT scanner
Smart mAGE HealthcareN/AAutomatic tube current modulation
Standard kernel (soft tissue)GE HealthcareN/AReconstruction kernel
TrueFidelity DLIR (Deep Learning Image Reconstruction), Medium strengthGE Healthcarehttps://www.gehealthcare.com/en-us/products/computed-tomography/applications/true-fidelityDeep learning image reconstruction

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Ultra-Low-Dose CTStandard-Dose CTCT Dose ComparisonDiagnostic AccuracyRadiation Dose ReductionImage Quality MetricsDeep Learning ReconstructionEndoscopic EvaluationPediatric CT Imaging
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