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

NCT06818214 | Not Yet Recruiting

• 1 other identifier: 2024-527
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• MRI, spectral CT and FAPI PET-CT combined with AI in prediction of lymph node status in esophageal cancer

  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.

  February 2025 - January 2030

Study Arms (2)

the group with lymph node metastasis in esophageal cancer

the group without lymph node metastasis in esophageal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are from the Esophageal Cancer Diagnosis and Treatment Center of the Affiliated Tumor Hospital of Zhengzhou University. Data will be collected from Feburary 2025 to January 2030, from patients with biopsy-confirmed esophageal cancer. Based on clinical needs, initial staging will be performed through EUS, spectral CT, or PET-CT. Patients who are planned for direct surgery will undergo MRI within 7 days prior to surgery; patients who are planned for neoadjuvant therapy will undergo spectral CT and MRI examinations both before neoadjuvant therapy and within 7 days before surgery.

You may qualify if:

• Consecutive patients with pathological diagnosis of esophageal cancer.
• 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.
• No history of malignant tumors or cancer-related treatments.
• Complete postoperative pathological data, allowing for a one-to-one comparison of preoperative lymph node imaging and postoperative histopathology for evaluation.

You may not qualify if:

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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

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

Central Study Contacts

Jinrong Qu

CONTACT

(86) 0371-65587595; qjryq@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 10, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 10, 2025

Record last verified: 2025-01