An observational study in Esophageal Squamous Cell Carcinoma, sponsored by The First Affiliated Hospital of Zhengzhou University. Not yet recruiting at 7 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by The First Affiliated Hospital of Zhengzhou University · Observational
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.
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.
675 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 267 are open to participants now.
This study's planned enrollment of 500 is above the median of 247 across 86 observational studies indexed under Esophageal Squamous Cell Carcinoma.
Browse Esophageal Squamous Cell Carcinoma studies →The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 126 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Standardized 3.0-T Esophageal Magnetic Resonance Imaging
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.
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.
Exact agreement between MRI-based and pathological T stage in Cohort A
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.
Time frame: 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
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.
Time frame: At postoperative pathological assessment following surgery performed within 14 days after the post-treatment MRI
Agreement within one T-stage category in Cohort A
Proportion of evaluable participants for whom mrT and pT differ by no more than one ordered T-stage category.
Time frame: At postoperative pathological assessment following surgery performed within 14 days after the preoperative MRI
MRI T-stage overstaging and understaging rates in Cohort A
Proportions of evaluable participants in whom mrT is higher than pT (overstaging) or lower than pT (understaging).
Time frame: 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
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.
Time frame: At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Interreader agreement for MRI T stage in Cohort A
Cohen kappa or weighted kappa calculated from the original independent mrT assessments of the two radiologists.
Time frame: 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
Cohen kappa or weighted kappa from repeat blinded assessment of at least 10% of randomly selected Cohort A examinations.
Time frame: 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
Weighted kappa, Spearman rank correlation, and exact agreement rate between mrTRG 1-4 and modified Ryan pTRG 0-3.
Time frame: 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
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.
Time frame: 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
Associations between treatment-related changes in tumor length, maximum wall thickness, volume, and apparent diffusion coefficient and postoperative pTRG.
Time frame: 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
Weighted kappa calculated from the original independent mrTRG assessments of the two radiologists.
Time frame: 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
Weighted kappa from repeat blinded assessment of at least 10% of randomly selected Cohort B paired examinations.
Time frame: At repeat central review performed at least 4 weeks after the initial image review
Core MRI sequence completion and protocol parameter adherence rates
Proportions of examinations that complete all required core sequences and meet the predefined parameter ranges in the standardized MRI protocol.
Time frame: From the first MRI examination through study completion, up to 2 years
Diagnostic image quality rate
Proportion of examinations graded as diagnostically acceptable (image quality grade 2-4 on the predefined four-level scale); grade 1 is nondiagnostic.
Time frame: From the first MRI examination through study completion, up to 2 years
Structured report completeness rate
Proportion of structured research reports in which all mandatory fields are completed.
Time frame: From the first MRI examination through study completion, up to 2 years
MRI acquisition time and structured reporting time
Duration in minutes for each MRI examination and for completion of the corresponding structured report; reasons for nonevaluable examinations will also be summarized.
Time frame: From the first MRI examination through study completion, up to 2 years
Specificity of mrT at prespecified pathological T-stage thresholds in Cohort A
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: At postoperative pathological assessment following surgery; preoperative MRI performed within 14 days before surgery
Specificity of mrTRG for pathological complete response in Cohort B
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: At postoperative pathological assessment following surgery; post-treatment MRI performed within 14 days before surgery
Difference in exact MRI-to-pathology T-stage agreement across prespecified subgroups in Cohort A
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.
Time frame: Through study completion, up to 2 years
Difference in AUROC for pathological good response across prespecified subgroups in Cohort B
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.
Time frame: Through study completion, up to 2 years
Plan to share: Undecided
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Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Esophageal Squamous Cell Carcinoma →
The First Affiliated Hospital of Zhengzhou University →