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NCT07769658

Standardized MRI and Structured Reporting for Esophageal Squamous Cell Carcinoma

Sponsor: The First Affiliated Hospital of Zhengzhou University

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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