Clinical trial NCT06412419: Multimodal Endoscopic Image Fusion for Assessing Infiltration in Superficial Esophageal Squamous Cell Carcinoma
Official title: Based on Multimodal Endoscopy and Weakly Supervised Deep Learning-Early Esophageal Squamous Cell Carcinoma Infiltration Depth Precise Prediction Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Esophageal Neoplasms Malignant
Keywords: Esophageal Neoplasms
multimodality
Endosonography
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: Shandong Provincial Hospital
name: The First Affiliated Hospital of Soochow University
name: The First Affiliated Hospital of Henan University of Science and Technology
name: THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY
First posted: 2024-05-14
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The study was executed in two distinct phases. The initial phase, designated as the modeling phase (Phase 1), involved a retrospective analysis of eligible subjects from a consortium of medical institutions, including the First Affiliated Hospital of Naval Medical University, West China Hospital of Sichuan University, Provincial Hospital Affiliated to Shandong First Medical University, the First Affiliated Hospital of Soochow University, the First Affiliated Hospital of Henan University of Science and Technology, and the First Affiliated Hospital of Shihezi University, all selected prior to January 1, 2024. The second phase, known as the real-world evaluation phase (Phase 2), prospectively enrolled consecutive patients who were scheduled to undergo magnometric endoscopy and EUS at the aforementioned hospitals between April 2024 and June 2024.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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.

Primary outcomes:
measure: Performance of models to diagnose low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and superficial esophageal squamous carcinoma
timeFrame: 2024.04.01-2024.10.30
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
Study officials:
affiliation: Changhai Hospital
name: Luowei Wang
role: STUDY_CHAIR
References: