Esophageal Squamous Cell CarcinomaESCC-MRI-TRGNCT07769658
Standardized MRI and Structured Reporting for Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University at 7 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Standardized 3.0-T Esophageal Magnetic Resonance Imaging
- How many people
- 500 participants
- Where
- 7 sitesChina
- Study dates
- Sep 2026to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
West China Hospital, Sichuan University
Chengdu, Sichuan
Xiangbo Wan, PhD, +86-371-66271152, shenzhibo233@163.com
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Xiangbo Wan, PhD, +86-371-66271152, shenzhibo233@163.com
Yunnan Cancer Hospital
Kunming, Yunnan
Xiangbo Wan, PhD, +86-371-66271152, shenzhibo233@163.com
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Xiangbo Wan, PhD, +86-371-66271152, shenzhibo233@163.com
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Xiangbo Wan, PhD, +86-371-66271152, shenzhibo233@163.com
Henan Provincial Chest Hospital (Zhengzhou University Affiliated Chest Hospital)
Zhengzhou, Henan
Xiangbo Wan, PhD, +86-371-66271152, shenzhibo233@163.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Xiangbo Wan, PhD, +86-371-66271152, shenzhibo233@163.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Standardized 3.0-T Esophageal Magnetic Resonance Imaging
- Keywords
- Esophageal magnetic resonance imaging, Structured reporting, T staging, Tumor regression grade, Diagnostic accuracy, Neoadjuvant therapy, Multicenter study
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized 3.0-T Esophageal Magnetic Resonance ImagingDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Standardized 3.0-T Esophageal Magnetic Resonance Imaging | |
| 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. Receives: Diagnostic Test: Standardized 3.0-T Esophageal Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At postoperative pathological assessment following surgery performed within 14 days after the post-treatment MRI
Secondary outcomes (23)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At postoperative pathological assessment following surgery; post-treatment MRI performed within 14 days before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangbo Wan, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Xiangbo Wan, PhD, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769658
- Sponsor's protocol ID
- MRI-ESCC-TTRG
- Acronym
- ESCC-MRI-TRG
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07769658
- Acronym / sponsor ID
- ESCC-MRI-TRG / MRI-ESCC-TTRG
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal magnetic resonance imaging, Structured reporting, T staging, Tumor regression grade, Diagnostic accuracy, Neoadjuvant therapy, Multicenter study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront Surgery T-Staging Cohort | – | Diagnostic Test: Standardized 3.0-T Esophageal Magnetic Resonance ImagingAdults 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. |
| Neoadjuvant Therapy Response Cohort | – | Diagnostic Test: Standardized 3.0-T Esophageal Magnetic Resonance ImagingAdults 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized 3.0-T Esophageal Magnetic Resonance ImagingA 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. | Diagnostic test | Neoadjuvant Therapy Response Cohort, Upfront Surgery T-Staging Cohort |
Primary outcome
Exact agreement between MRI-based and pathological T stage in Cohort A
Time frame: 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
Time frame: 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.
23 secondary outcomes
Agreement within one T-stage category in Cohort A
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
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
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
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
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
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
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
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
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
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
Time frame: From the first MRI examination through study completion, up to 2 years
Diagnostic image quality rate
Time frame: From the first MRI examination through study completion, up to 2 years
Structured report completeness rate
Time frame: From the first MRI examination through study completion, up to 2 years
MRI acquisition time and structured reporting time
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
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
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
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
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
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
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
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
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
Time frame: At postoperative pathological assessment following surgery; post-treatment MRI performed within 14 days before surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Esophageal Squamous Cell Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
Not yet recruitingPhase 3
Circulating Tumor DNA MRD-Guided Adjuvant Therapy for Curatively Resected Locally Advanced Esophageal Squamous Cell Carcinoma
Esophageal Cancer
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
RecruitingPhase 2
Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
Esophageal Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiangbo Wan, PhD principal investigator
The First Affiliated Hospital of Zhengzhou University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangbo Wan, PhD (+86-371-66271152, shenzhibo233@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exact agreement between MRI-based and pathological T stage in Cohort A (time frame: At postoperative pathological assessment following surgery performed within 14 days after the preoperative MRI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.