Standardized MRI and Structured Reporting for Esophageal Squamous Cell Carcinoma

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Exact agreement between MRI-based and pathological T stage in Cohort A — At postoperative pathological assessment following surgery performed within 14 days after the preoperative MRI
  Proportion of evaluable Cohort A participants for whom the four-category structured MRI T stage (mrT1, mrT2, mrT3, or mrT4a) exactly matches postoperative pathological T stage (pT1, pT2, pT3, or pT4a). Linear weighted kappa and its 95% confidence interval will also be reported.
• Area under the ROC curve of mrTRG for pathological good response in Cohort B — At postoperative pathological assessment following surgery performed within 14 days after the post-treatment MRI
  Area under the receiver operating characteristic curve and 95% confidence interval for four-level MRI tumor regression grade (mrTRG 1-4) to identify pathological good response, defined as modified Ryan pTRG 0-1 versus pTRG 2-3. The prespecified imaging dichotomy is mrTRG 1-2 versus mrTRG 3-4.

Trial sites (7)

More The First Affiliated Hospital of Zhengzhou University trials in China

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