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