Mechanistic Study on the Diagnosis of Esophageal Cancer Lymph Node Metastasis Using Spectral CT, Multimodal MRI, FAPI PET-CT, Pathology, and AI Evaluation System

Not yet recruiting

• Conditions: Esophageal Cancer

• Registration Number: NCT06818214
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

The objective of this study is to address the urgent issues in the diagnosis of lymph node metastasis in esophageal cancer. By employing multimodal MRI, spectral CT imaging and FAPI PET-CTtechniques, the study will correlate lymph node images with postoperative pathology results. Additionally, AI technology will be applied to learn from multimodal imaging data, enabling comprehensive analysis and evaluation of lymph node metastasis. Using a large volume of clinical and imaging data, a predictive model will be established to provide individualized lymph node metastasis risk assessments for each esophageal cancer patient. This will, in turn, offer robust support for personalized treatment strategies in esophageal cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study Start: 2025-02
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Primary Completion: 2030-01
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Consecutive patients with pathological diagnosis of esophageal cancer.
2. Patients underwent radical esophagectomy and lymph node dissection, with preoperative multimodal MRI, spectral CT and FAPI PET-CT ; patients underwent neoadjuvant therapy followed by radical surgery, with preoperative multimodal MRI, spectral CT and FAPI PET-CTboth before and after neoadjuvant therapy.
3. No history of malignant tumors or cancer-related treatments.
4. Complete postoperative pathological data, allowing for a one-to-one comparison of preoperative lymph node imaging and postoperative histopathology for evaluation.

Exclusion Criteria

1. Contraindications for MRI, spectral CT or FAPI PET-CT.
2. Patients who refuse to participate in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MRI, spectral CT and FAPI PET-CT combined with AI in prediction of lymph node status in esophageal cancer	February 2025 - January 2030	To evaluate the effectiveness of multimodal MRI, spectral CT imaging, and FAPI PET-CT combined with AI in determining the preoperative lymph node status (presence or absence of metastasis) in patients with esophageal cancer, with confirmation through pathological assessment.