Multimodal Endoscopic Image Fusion for Assessing Infiltration in Superficial Esophageal Squamous Cell Carcinoma

NCT06412419 | Not Yet Recruiting DMC

• 1 other identifier: MEIFI-sESCC
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this project is to pioneer a novel protocol for the adjunctive screening of early-stage esophageal cancer and its precancerous lesions. The anticipated outcomes include simplifying the training process for users, shortening the duration of examinations, and achieving a more precise assessment of the extent of esophageal cancer invasion than what is currently possible with ultrasound technology. This research endeavors to harness the synergy of endoscopic ultrasound (EUS) and Magnifying endoscopy, augmented by the pattern recognition and correlation capabilities of artificial intelligence (AI), to detect early esophageal squamous cell carcinoma and its invasiveness, along with high-grade intraepithelial neoplasia. The overarching goal is to ascertain the potential and significance of this approach in the early detection of esophageal cancer. The project's primary goals are to develop three distinct AI-assisted diagnostic systems: An AI-driven electronic endoscopic diagnosis system designed to autonomously identify lesions. An AI-based EUS diagnostic system capable of automatically delineating the affected areas. A multimodal diagnostic framework that integrates electronic endoscopy with EUS to enhance diagnostic accuracy and efficiency.

Conditions

Esophageal Neoplasms Malignant

Keywords

Esophageal Neoplasms; multimodality; Endosonography

Outcome Measures

Primary Outcomes (1)

• Performance of models to diagnose low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and superficial esophageal squamous carcinoma

  Endoscopic Submucosal Dissection (ESD) serving as the gold standard. Computation of sensitivity and specificity involves the use of four fundamental metrics: true positive (TP), true negative (TN), false negative (FN), and false positive (FP). Subsequently, the Area Under the Curve (AUC) is utilized to assess the diagnostic efficacy of the model.

  2024.04.01-2024.10.30

Study Arms (4)

Low-grade intraepithelial neoplasia of esophageal squamous epithelium

Diagnostic Test: Magnifying Endoscopy and Endoscopic Ultrasonography

High-grade intraepithelial neoplasia of esophageal squamous epithelium

Diagnostic Test: Magnifying Endoscopy and Endoscopic Ultrasonography

Stage T1a esophageal squamous cell carcinoma

Diagnostic Test: Magnifying Endoscopy and Endoscopic Ultrasonography

Stage T1b esophageal squamous cell carcinoma

Diagnostic Test: Magnifying Endoscopy and Endoscopic Ultrasonography

Interventions

Magnifying Endoscopy and Endoscopic Ultrasonography DIAGNOSTIC_TEST

The acquired magnifying endoscopy and endoscopic ultrasonography images were shared with artificial intelligence for machine learning, diagnostic modeling and optimization. In the real world evaluation phase, the high-risk population of early esophageal cancer who planned to undergo esophageal electronic endoscopy were prospectively enrolled. The artificial intelligence-assisted diagnosis system was used for prediction before surgery, and the postoperative pathological results were used as the gold standard to diagnose by grouping.

High-grade intraepithelial neoplasia of esophageal squamous epithelium; Low-grade intraepithelial neoplasia of esophageal squamous epithelium; Stage T1a esophageal squamous cell carcinoma; Stage T1b esophageal squamous cell carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study was conducted in two phases. The initial stage was the modeling stage (the first stage), which included patients from six hospitals including the First Affiliated Hospital of Naval Medical University before January 1, 2024. The second phase, called real-world evaluation phase (phase 2), prospectively enrolled consecutive patients scheduled to undergo magnifying endoscopy and EUS at the aforementioned hospitals between April and June 2024.

You may qualify if:

• Patients requiring magnifying endoscopy and endoscopic ultrasonography. Individuals of either sex, aged 18 years or older.

You may not qualify if:

• Inability to complete esophageal electronic endoscopy. Absence of biopsy or surgery, resulting in unobtainable pathological results. Patients who have undergone endoscopic lesion destruction or piecemeal resection, preventing the acquisition of an en bloc resection sample.
• Patients with significant endoscopic, imaging, or pathological evidence of advanced esophageal cancer.
• Patients presenting with marked esophageal stenosis or dilatation. Individuals with a history of other malignancies. Patients who have received neoadjuvant radiotherapy. Patients who declined to participate in the study and did not provide informed consent.

Sponsors & Collaborators

• Changhai Hospital: lead
• West China Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• The First Affiliated Hospital of Henan University of Science and Technology: collaborator
• THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY: collaborator

Study Sites (1)

Changhai hospital

Shanghai, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Luowei Wang

  Changhai Hospital

  STUDY CHAIR

Central Study Contacts

Luowei Wang

CONTACT

86-21-31161337; wangluoweimd@smmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 14, 2024
• Study Start: May 15, 2024
• Primary Completion: August 30, 2024
• Study Completion: October 30, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)