NCT07769658Not yet recruiting
Standardized MRI and Structured Reporting for Esophageal Squamous Cell Carcinoma
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
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 5 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07769658
What you commit to
- Study type: Observational
- Planned participants: 500
- From 1 Sept 2026 to the primary completion date, 30 Sept 2028
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous esophageal cancer surgery, radiotherapy, or another treatment that substantially altered local esophageal anatomy
- Inadequate surgical specimen sampling or inability to determine pathological T stage or pathological tumor regression grade
Other illness
- 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
- Substantial disease progression, emergency intervention, or off-protocol treatment between MRI and surgery that prevents valid imaging-pathology comparison
Other
- Adenocarcinoma, neuroendocrine carcinoma, adenosquamous carcinoma, or another non-squamous histological type
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Henan Provincial Chest Hospital (Zhengzhou University Affiliated Chest Hospital) Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.