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Standardized MRI and Structured Reporting for Esophageal Squamous Cell Carcinoma
Sponsor: The First Affiliated Hospital of Zhengzhou University
Summary
This prospective, multicenter diagnostic accuracy study will develop and validate a standardized 3.0-T magnetic resonance imaging (MRI) acquisition protocol and structured reporting system for primary esophageal squamous cell carcinoma (ESCC). Approximately 500 adults scheduled for curative esophagectomy will be enrolled consecutively into two clinically defined cohorts. In Cohort A, patients proceeding directly to surgery will have MRI-based T staging compared with postoperative pathological T stage. In Cohort B, patients receiving neoadjuvant therapy before surgery will undergo paired MRI assessment, and MRI-based tumor regression grade will be compared with pathological tumor regression grade in the resected primary tumor bed. Imaging will be independently assessed by two radiologists, with adjudication by a third reader. The study will evaluate diagnostic performance, reader agreement, image quality, protocol adherence, reporting completeness, and consistency across participating centers and MRI vendors. Lymph-node staging and nodal treatment response are outside the research scope.
Official title: Development and Multicenter Validation of Standardized MRI Acquisition and Structured Reporting for Primary Esophageal Squamous Cell Carcinoma: A Dual-Cohort Study of T Staging and Tumor Regression Grading
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2026-09
Completion Date
2028-09
Last Updated
2026-08-18
Healthy Volunteers
No
Conditions
Interventions
Standardized 3.0-T Esophageal Magnetic Resonance Imaging
A standardized 3.0-T esophageal MRI framework comprising large-coverage and tumor-oriented T2-weighted imaging, high-resolution oblique axial T2-weighted imaging, diffusion-weighted imaging with apparent diffusion coefficient maps, and three-dimensional T1-weighted imaging before and after gadolinium contrast administration. Cohort A has one preoperative examination within 14 days before surgery. Cohort B has a baseline examination within 14 days before neoadjuvant treatment and a post-treatment examination within 14 days before surgery. Images are evaluated with predefined structured mrT or mrTRG criteria.
Locations (7)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Henan Provincial Chest Hospital (Zhengzhou University Affiliated Chest Hospital)
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China