Standardized MRI and Structured Reporting for Esophageal Squamous Cell Carcinoma

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 to 80 years, inclusive

Histologically confirmed esophageal squamous cell carcinoma based on endoscopic biopsy or other tissue examination

Primary tumor located in the thoracic esophagus

Planned curative esophagectomy

Disqualifiers

Adenocarcinoma, neuroendocrine carcinoma, adenosquamous carcinoma, or another non-squamous histological type

Cervical esophageal cancer, a gastric primary tumor extending into the esophagus, or multiple primary lesions that prevent reliable imaging-pathology matching

Definite distant metastasis, unresectable T4b disease, or another reason that prevents acquisition of a surgical pathological reference standard

Previous esophageal cancer surgery, radiotherapy, or another treatment that substantially altered local esophageal anatomy

Trial design

Treatments tested in this trial

  • Standardized 3.0-T Esophageal Magnetic Resonance Imaging

Treatment groups

500 Participants
are divided into 2 treatment groups