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Standardized MRI and Structured Reporting for Esophageal Squamous Cell Carcinoma (ESCC-MRI-TRG)

12 de agosto de 2026 atualizado por: Xiangbo Wan, The First Affiliated Hospital of Zhengzhou University

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

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This investigator-initiated, prospective, multicenter, dual-cohort diagnostic accuracy study uses a common standardized 3.0-T esophageal MRI framework. The clinical treatment pathway, including whether a patient proceeds directly to surgery or receives neoadjuvant therapy before surgery, is determined by the treating multidisciplinary team independently of study participation. The MRI examinations are performed as part of routine clinical care. Participants are classified into one of two cohorts according to their clinical pathway.

Cohort A includes patients who have received no antitumor treatment before MRI and are scheduled for upfront esophagectomy. MRI is performed within 14 days before surgery. Structured MRI-based T stage (mrT1, mrT2, mrT3, or mrT4a) is compared with postoperative pathological T stage.

Cohort B includes patients scheduled to receive neoadjuvant chemoradiotherapy, chemotherapy, or immunotherapy combined with chemotherapy according to routine clinical decision-making, followed by esophagectomy. Baseline MRI is performed within 14 days before neoadjuvant treatment, and a second MRI is performed after treatment and within 14 days before surgery. Paired examinations are assigned an MRI tumor regression grade (mrTRG 1-4) and compared with pathological tumor regression grade in the resected primary tumor bed using the modified Ryan system (pTRG 0-3). Pathological good response is defined as pTRG 0-1, and the prespecified imaging dichotomy is mrTRG 1-2 versus mrTRG 3-4.

The core MRI framework includes large-coverage T2-weighted imaging, tumor-axis and 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. Participating scanners undergo parameter mapping, test-scan certification, and ongoing central quality control.

Each examination is interpreted independently by two trained radiologists who are blinded to postoperative pathology, other imaging-stage results, endoscopic stage, and clinical response conclusions. Disagreements are adjudicated by a third senior radiologist. Pathological pT or pTRG is assessed by two gastrointestinal pathologists blinded to the MRI results, with adjudication when needed. At least 10% of cases are reread after an interval of at least 4 weeks to assess intrareader agreement.

A total of 500 participants are planned, with 250 participants in each cohort. Consecutive enrollment will be used, and no single center should contribute more than 40% of the total sample. The study evaluates only the primary esophageal tumor. Lymph-node imaging features, N stage, and nodal treatment response are not collected for research analysis.

Tipo de estudo

Observacional

Inscrição (Estimado)

500

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center
        • Contato:
    • Henan
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University
        • Contato:
      • Zhengzhou, Henan, China
        • Henan Provincial Chest Hospital (Zhengzhou University Affiliated Chest Hospital)
        • Contato:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Fudan University Shanghai Cancer Center
        • Contato:
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital, Sichuan University
        • Contato:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Tianjin Medical University Cancer Institute and Hospital
        • Contato:
    • Yunnan
      • Kunming, Yunnan, China
        • Yunnan Cancer Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra de Probabilidade

População do estudo

Adults aged 18-80 years with histologically confirmed thoracic esophageal squamous cell carcinoma who are scheduled for curative esophagectomy at seven tertiary hospitals in China. Eligible patients will be enrolled consecutively. Cohort membership is determined by the clinical treatment pathway (upfront surgery or neoadjuvant therapy followed by surgery) selected by the treating multidisciplinary team independently of study participation. MRI examinations are performed as part of routine clinical care.

Descrição

Inclusion Criteria:

  • 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
  • Able to complete the required esophageal MRI examination with diagnostically adequate image quality
  • Able and willing to provide written informed consent
  • For Cohort A: no chemotherapy, radiotherapy, immunotherapy, targeted therapy, or other antitumor treatment before MRI; surgery planned within 14 days after MRI; and postoperative pathological T stage expected to be available
  • For Cohort B: neoadjuvant treatment followed by surgery selected by the clinical multidisciplinary team; baseline MRI completed within 14 days before neoadjuvant treatment; post-treatment MRI completed within 14 days before surgery; and pathological tumor regression grade of the primary tumor bed expected to be available

Exclusion Criteria:

  • 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
  • Contraindication to MRI, or contraindication to the gadolinium-based contrast agent when the required contrast-enhanced sequences cannot be completed
  • Severe claustrophobia, inability to follow breathing instructions, or another cause of nondiagnostic image quality that persists after a safe repeat examination
  • Substantial disease progression, emergency intervention, or off-protocol treatment between MRI and surgery that prevents valid imaging-pathology comparison
  • Inadequate surgical specimen sampling or inability to determine pathological T stage or pathological tumor regression grade

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Upfront Surgery T-Staging Cohort
Adults with thoracic esophageal squamous cell carcinoma who have received no antitumor treatment before MRI and are scheduled for upfront curative esophagectomy. A standardized preoperative esophageal MRI examination is obtained within 14 days before surgery, and structured mrT is compared with postoperative pT.
Teste de diagnostico: 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.
Neoadjuvant Therapy Response Cohort
Adults with thoracic esophageal squamous cell carcinoma whose multidisciplinary clinical team has selected neoadjuvant therapy followed by curative esophagectomy. Baseline and post-treatment standardized esophageal MRI examinations are evaluated as a pair, and mrTRG is compared with postoperative pTRG in the primary tumor bed.
Teste de diagnostico: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Exact agreement between MRI-based and pathological T stage in Cohort A
Prazo: 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.
At postoperative pathological assessment following surgery performed within 14 days after the preoperative MRI
Area under the ROC curve of mrTRG for pathological good response in Cohort B
Prazo: 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.
At postoperative pathological assessment following surgery performed within 14 days after the post-treatment MRI

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Agreement within one T-stage category in Cohort A
Prazo: At postoperative pathological assessment following surgery performed within 14 days after the preoperative MRI
Proportion of evaluable participants for whom mrT and pT differ by no more than one ordered T-stage category.
At postoperative pathological assessment following surgery performed within 14 days after the preoperative MRI
MRI T-stage overstaging and understaging rates in Cohort A
Prazo: At postoperative pathological assessment following surgery performed within 14 days after the preoperative MRI
Proportions of evaluable participants in whom mrT is higher than pT (overstaging) or lower than pT (understaging).
At postoperative pathological assessment following surgery performed within 14 days after the preoperative MRI
Sensitivity of mrT at prespecified pathological T-stage thresholds in Cohort A
Prazo: At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Sensitivity (percentage) of structured MRI T staging for detecting pT2 or higher and pT3-pT4a disease. Results will be reported separately for each prespecified threshold using postoperative pathological T stage as the reference standard.
At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Interreader agreement for MRI T stage in Cohort A
Prazo: At the initial blinded central MRI review in Cohort A, through study completion (up to 2 years)
Cohen kappa or weighted kappa calculated from the original independent mrT assessments of the two radiologists.
At the initial blinded central MRI review in Cohort A, through study completion (up to 2 years)
Intrareader agreement for MRI T stage in Cohort A
Prazo: At repeat central review performed at least 4 weeks after the initial image review
Cohen kappa or weighted kappa from repeat blinded assessment of at least 10% of randomly selected Cohort A examinations.
At repeat central review performed at least 4 weeks after the initial image review
Agreement and rank correlation between four-level mrTRG and pTRG in Cohort B
Prazo: At postoperative pathological assessment following surgery performed within 14 days after the post-treatment MRI
Weighted kappa, Spearman rank correlation, and exact agreement rate between mrTRG 1-4 and modified Ryan pTRG 0-3.
At postoperative pathological assessment following surgery performed within 14 days after the post-treatment MRI
Sensitivity of mrTRG for pathological complete response in Cohort B
Prazo: At postoperative pathological assessment following surgery; post-treatment MRI performed within 14 days before surgery
Sensitivity (percentage) of MRI tumor regression grade at each prespecified mrTRG threshold for identifying pathological complete response, defined as modified Ryan pTRG 0, using postoperative pathology as the reference standard.
At postoperative pathological assessment following surgery; post-treatment MRI performed within 14 days before surgery
Association of quantitative MRI changes with pathological tumor regression grade in Cohort B
Prazo: From baseline MRI within 14 days before neoadjuvant treatment through postoperative pathological assessment after post-treatment MRI and surgery
Associations between treatment-related changes in tumor length, maximum wall thickness, volume, and apparent diffusion coefficient and postoperative pTRG.
From baseline MRI within 14 days before neoadjuvant treatment through postoperative pathological assessment after post-treatment MRI and surgery
Interreader agreement for MRI tumor regression grade in Cohort B
Prazo: At the initial blinded central review of paired baseline and post-treatment MRI examinations in Cohort B, through study completion (up to 2 years)
Weighted kappa calculated from the original independent mrTRG assessments of the two radiologists.
At the initial blinded central review of paired baseline and post-treatment MRI examinations in Cohort B, through study completion (up to 2 years)
Intrareader agreement for MRI tumor regression grade in Cohort B
Prazo: At repeat central review performed at least 4 weeks after the initial image review
Weighted kappa from repeat blinded assessment of at least 10% of randomly selected Cohort B paired examinations.
At repeat central review performed at least 4 weeks after the initial image review
Core MRI sequence completion and protocol parameter adherence rates
Prazo: From the first MRI examination through study completion, up to 2 years
Proportions of examinations that complete all required core sequences and meet the predefined parameter ranges in the standardized MRI protocol.
From the first MRI examination through study completion, up to 2 years
Diagnostic image quality rate
Prazo: From the first MRI examination through study completion, up to 2 years
Proportion of examinations graded as diagnostically acceptable (image quality grade 2-4 on the predefined four-level scale); grade 1 is nondiagnostic.
From the first MRI examination through study completion, up to 2 years
Structured report completeness rate
Prazo: From the first MRI examination through study completion, up to 2 years
Proportion of structured research reports in which all mandatory fields are completed.
From the first MRI examination through study completion, up to 2 years
MRI acquisition time and structured reporting time
Prazo: From the first MRI examination through study completion, up to 2 years
Duration in minutes for each MRI examination and for completion of the corresponding structured report; reasons for nonevaluable examinations will also be summarized.
From the first MRI examination through study completion, up to 2 years
Specificity of mrT at prespecified pathological T-stage thresholds in Cohort A
Prazo: At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Specificity (percentage) of structured MRI T staging for detecting pT2 or higher and pT3-pT4a disease. Results will be reported separately for each prespecified threshold using postoperative pathological T stage as the reference standard.
At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Positive predictive value of mrT at prespecified pathological T-stage thresholds in Cohort A
Prazo: At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Positive predictive value (percentage) of structured MRI T staging for detecting pT2 or higher and pT3-pT4a disease. Results will be reported separately for each prespecified threshold using postoperative pathological T stage as the reference standard.
At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Negative predictive value of mrT at prespecified pathological T-stage thresholds in Cohort A
Prazo: At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Negative predictive value (percentage) of structured MRI T staging for detecting pT2 or higher and pT3-pT4a disease. Results will be reported separately for each prespecified threshold using postoperative pathological T stage as the reference standard.
At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Accuracy of mrT at prespecified pathological T-stage thresholds in Cohort A
Prazo: At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Accuracy (percentage) of structured MRI T staging for detecting pT2 or higher and pT3-pT4a disease. Results will be reported separately for each prespecified threshold using postoperative pathological T stage as the reference standard.
At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Area under the ROC curve of mrT at prespecified pathological T-stage thresholds in Cohort A
Prazo: At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Area under the receiver operating characteristic curve for structured MRI T staging at the prespecified pT2-or-higher and pT3-pT4a thresholds. Each threshold will be reported separately using postoperative pathological T stage as the reference standard.
At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Specificity of mrTRG for pathological complete response in Cohort B
Prazo: At postoperative pathological assessment following surgery; post-treatment MRI performed within 14 days before surgery
Specificity (percentage) of MRI tumor regression grade at each prespecified mrTRG threshold for identifying pathological complete response, defined as modified Ryan pTRG 0, using postoperative pathology as the reference standard.
At postoperative pathological assessment following surgery; post-treatment MRI performed within 14 days before surgery
Positive predictive value of mrTRG for pathological complete response in Cohort B
Prazo: At postoperative pathological assessment following surgery; post-treatment MRI performed within 14 days before surgery
Positive predictive value (percentage) of MRI tumor regression grade at each prespecified mrTRG threshold for identifying pathological complete response, defined as modified Ryan pTRG 0, using postoperative pathology as the reference standard.
At postoperative pathological assessment following surgery; post-treatment MRI performed within 14 days before surgery
Negative predictive value of mrTRG for pathological complete response in Cohort B
Prazo: At postoperative pathological assessment following surgery; post-treatment MRI performed within 14 days before surgery
Negative predictive value (percentage) of MRI tumor regression grade at each prespecified mrTRG threshold for identifying pathological complete response, defined as modified Ryan pTRG 0, using postoperative pathology as the reference standard.
At postoperative pathological assessment following surgery; post-treatment MRI performed within 14 days before surgery
Area under the ROC curve of mrTRG for pathological complete response in Cohort B
Prazo: At postoperative pathological assessment following surgery; post-treatment MRI performed within 14 days before surgery
Area under the receiver operating characteristic curve for MRI tumor regression grade to identify pathological complete response, defined as modified Ryan pTRG 0, using postoperative pathology as the reference standard.
At postoperative pathological assessment following surgery; post-treatment MRI performed within 14 days before surgery

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Difference in exact MRI-to-pathology T-stage agreement across prespecified subgroups in Cohort A
Prazo: Through study completion, up to 2 years
Percentage-point differences in exact mrT-pT agreement across center, MRI vendor, tumor location, image quality category, and reader-experience category. Each subgroup comparison will be reported separately; mixed-effects and leave-one-center-out sensitivity analyses will assess robustness.
Through study completion, up to 2 years
Difference in AUROC for pathological good response across prespecified subgroups in Cohort B
Prazo: Through study completion, up to 2 years
Differences in area under the receiver operating characteristic curve for mrTRG identification of pathological good response (modified Ryan pTRG 0-1) across center, MRI vendor, tumor location, image quality category, reader-experience category, and neoadjuvant-treatment type. Each comparison will be reported separately; mixed-effects and leave-one-center-out sensitivity analyses will assess robustness.
Through study completion, up to 2 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The First Affiliated Hospital of Zhengzhou University

Investigadores

  • Investigador principal: Xiangbo Wan, PhD, The First Affiliated Hospital of Zhengzhou University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de setembro de 2028

Conclusão do estudo (Estimado)

1 de setembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

5 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de agosto de 2026

Primeira postagem (Real)

18 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • MRI-ESCC-TTRG

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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