Photon-Counting CT for Detection of Small Gastrointestinal Lesions: Comparison With Energy-Integrating Detector Dual-Energy CT and Prospective Clinical Implementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,762
- 试验地点
- 1
- 主要终点
- Lesion-Based Detection Rate
研究概览
简要总结
This comparative matched-cohort study aims to evaluate the diagnostic performance of contrast-enhanced photon-counting computed tomography (PCCT) for detecting small gastrointestinal lesions compared with energy-integrating detector dual-energy computed tomography (DECT). The study includes a prospectively enrolled PCCT cohort and a retrospectively identified DECT cohort. Endoscopy with histopathology serves as the reference standard. Primary evaluation focuses on lesion detection, with additional assessment of lesion characterization, image quality, quantitative imaging parameters, and interobserver agreement.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 years.
- •Patients undergoing contrast-enhanced abdominal CT (photon-counting CT or energy-integrating detector dual-energy CT).
- •At least one endoscopically detected or clinically suspected small gastrointestinal lesion.
- •Lesions confirmed or suspected on endoscopy, pathology, or follow-up imaging.
- •Lesions characterized as mucosal thickening or nodular lesions within predefined size criteria (≤2 cm).
排除标准
- •Prior gastrointestinal surgery affecting target evaluation region.
- •Poor or nondiagnostic CT image quality.
- •Incomplete or unavailable endoscopic or histopathological reference standard.
- •Ambiguous lesion localization on endoscopy or imaging.
- •Severe motion artifacts or inadequate bowel distension affecting diagnostic evaluation.
研究组 & 干预措施
DECT Diagnostic Cohort
Retrospectively identified adults who underwent contrast-enhanced energy-integrating detector dual-energy computed tomography (DECT) for evaluation of suspected small gastrointestinal lesions. Eligible patients were matched 1:1 with the prospective PCCT cohort using propensity score matching for diagnostic performance comparison.
干预措施: Contrast-Enhanced Energy-Integrating Detector Dual-Energy Computed Tomography (Diagnostic Test)
Prospective Clinical Implementation Cohort
Consecutive adults undergoing routine contrast-enhanced abdominal photon-counting computed tomography (PCCT) in clinical practice. Patients with CT-positive findings suggestive of small gastrointestinal lesions were referred for endoscopy when appropriate to evaluate the clinical implementation of PCCT.
干预措施: Contrast-Enhanced Photon-Counting Computed Tomography (Diagnostic Test)
PCCT Diagnostic Cohort
Prospectively enrolled adults who underwent contrast-enhanced photon-counting computed tomography (PCCT) for evaluation of suspected small gastrointestinal lesions. Patients meeting the eligibility criteria were included in the diagnostic performance cohort and subsequently matched 1:1 with the retrospective DECT cohort using propensity score matching.
干预措施: Contrast-Enhanced Photon-Counting Computed Tomography (Diagnostic Test)
结局指标
主要结局
Lesion-Based Detection Rate
时间窗: During the study period (January 2026 - March 2026)
Lesion-based detection rate of contrast-enhanced photon-counting CT compared with energy-integrating detector dual-energy CT using endoscopy with histopathology, when available, as the reference standard.
次要结局
- Positive Predictive Value of CT-Positive Findings(During the study period (March 2026 to June 2026))
- Yield of Clinically Actionable Lesions(During the study period (March 2026 to June 2026))
- Lesion-to-Mucosa Attenuation Difference(During the study period (January 2026 - March 2026))
- Image Noise(During the study period (January 2026 - March 2026))
- Signal-to-Noise Ratio(During the study period (January 2026 - March 2026))
- Contrast-to-Noise Ratio(During the study period (January 2026 - March 2026))
- Subjective Image Quality Score(During the study period (January 2026 - March 2026))
- Interobserver Agreement for Lesion Detection(During the study period (January 2026 - June 2026))
- Interobserver Agreement for Lesion Size Measurement(During the study period (January 2026 - June 2026))
- Interobserver Agreement for Diagnostic Confidence(During the study period (January 2026 - March 2026))