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

NCT06755866 | Recruiting

• 1 other identifier: KYLX2024-273
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Application of DCE-MRI based on 4D Free Breathing in predicting the efficacy of preoperative neoadju

EXPERIMENTAL

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

Interventions

The application value of MRI 4D Free Breathing DCE-MRI in the treatment of esophageal cancer DIAGNOSTIC_TEST

Chest MRI scan outside of standard treatment options

Application of DCE-MRI based on 4D Free Breathing in predicting the efficacy of preoperative neoadju

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yunnan Cancer Hospital: lead

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Lianhua Ye

  Ethics Committee of Yunnan Provincial Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

ruiling Yang

CONTACT

17390212095; 1516559633@qq.com

zhenhui Li

CONTACT

13698736132; lizhenhui@kmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: January 1, 2025
• Study Start: November 26, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

CN (1)