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Standardized MRI and Structured Reporting for Esophageal Squamous Cell Carcinoma

NCT07769658 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-08-18

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Principal Investigators

  • Xiangbo Wan, PhD · The First Affiliated Hospital of Zhengzhou University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-09-30
Completion
2028-09-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07769658 on ClinicalTrials.gov