DCE-MRI Based on 4D Free Breathing for Predicting Preoperative Neoadjuvant Chemoradiotherapy for Esophageal Cancer

To prospectively collect medical images and clinical data related to esophageal cancer using 4D Free Breathing DCE-MRI technology, to evaluate the image quality in the diagnosis of esophageal cancer, and to predict the efficacy of preoperative neoadjuvant chemoradiotherapy for esophageal cancer.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Diagnostic test: The application value of MRI 4D Free Breathing DCE-MRI in the treatment of esophageal cancer

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhenhui LI; Phone Number: 13698736132; Email: lizhenhui@kmmu.edu.cn
• Study Contact Backup: Name: ruiling Yang; Phone Number: 17390212095; Email: 1516559633@qq.com

Study Locations

• China
  • Yunnan
    • Kunming City, Yunnan, China
      • Recruiting
      • Yunnan Cancer Hospital
      • Contact: Guojun Zhang; Phone Number: r 0871-68173640

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be 18 years of age and older;
2. First diagnosis of esophageal squamous cell carcinoma confirmed by histopathological biopsy;
3. The clinical stage is cT1b~cT2N+; or the clinical stage is cT3~cT4 any N, (thoracic esophageal cancer, esophagogastric junction cancer);
4. There are no contraindications to MRI examination

Exclusion Criteria:

1. Have other primary tumors;
2. The image quality does not meet the diagnostic criteria;
3. Those who do not cooperate with the inspection;
4. Patients who have received prior chemoradiotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Application of DCE-MRI based on 4D Free Breathing in predicting the efficacy of preoperative neoadju; Prospective collection uses a Philips 3.0T MRI scanner equipped with a dStream Torso 32-channel coil. DCE-MRI was performed using a free respiration sequence with a flow rate of 3.0 m/s. The medical images and clinical data related to esophageal cancer using 4D Free Breathing DCE-MRI technology were performed by two radiologists (one with 3 years of diagnostic experience and the other with 15 years of diagnostic experience), including subjective and objective assessment of image quality in the diagnosis of esophageal cancer, and the use of this technology to predict the efficacy of preoperative neoadjuvant chemoradiotherapy for esophageal cancer with pathological PCR as the outcome.

Diagnostic test: The application value of MRI 4D Free Breathing DCE-MRI in the treatment of esophageal cancer; Chest MRI scan outside of standard treatment options

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response assessment	This study aims to assess tumor treatment response using pathology gold standard pCR . pCR refers to the state in which the pathological tumor completely disappears after systemic therapy, such as chemotherapy, targeted therapy, or endocrine therapy.	Surgery was performed within one month after neoadjuvant therapy, and the pathological pCR of the pathological results obtained from the surgery was used as the gold standard in this study to evaluate tumor treatment response

Collaborators and Investigators

• Sponsor: Yunnan Cancer Hospital
• Investigators: Study Director: Lianhua Ye, Ethics Committee of Yunnan Provincial Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 15, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: KYLX2024-273

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No