Photon-Counting CT for Detection of Small Gastrointestinal Lesions

NCT07748923 | Completed

• 1 other identifier: 2026EC041
• Study Type: observational
• Target: 1,762
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Small Gastrointestinal Lesions

Outcome Measures

Primary Outcomes (1)

• Lesion-Based Detection Rate

  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.

  During the study period (January 2026 - March 2026)

Secondary Outcomes (10)

• 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)

Study Arms (3)

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.

Diagnostic Test: Contrast-Enhanced Photon-Counting Computed Tomography

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.

Diagnostic Test: Contrast-Enhanced Energy-Integrating Detector Dual-Energy Computed Tomography

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.

Diagnostic Test: Contrast-Enhanced Photon-Counting Computed Tomography

Interventions

Contrast-Enhanced Photon-Counting Computed Tomography DIAGNOSTIC_TEST

Contrast-enhanced abdominal photon-counting computed tomography performed for the detection and characterization of small gastrointestinal lesions.

Also known as: PCCT

PCCT Diagnostic Cohort; Prospective Clinical Implementation Cohort

Contrast-Enhanced Energy-Integrating Detector Dual-Energy Computed Tomography DIAGNOSTIC_TEST

Contrast-enhanced abdominal energy-integrating detector dual-energy computed tomography performed for comparison of diagnostic performance in detecting and characterizing small gastrointestinal lesions.

Also known as: DECT

DECT Diagnostic Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes two cohorts: a retrospective diagnostic-performance cohort and a prospective clinical implementation cohort. Patients underwent contrast-enhanced photon-counting CT (PCCT) or energy-integrating detector dual-energy CT (DECT) for evaluation of suspected small gastrointestinal lesions in a clinical setting.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: August 6, 2026
• Study Start: September 18, 2023
• Primary Completion: January 9, 2026
• Study Completion: May 21, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)