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

February 4, 2025 updated by: Qujinrong, Henan Cancer Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jinrong Qu
  • Phone Number: (86) 0371-65587595
  • Email: qjryq@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
the group with lymph node metastasis in esophageal cancer
the group without lymph node metastasis in esophageal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI, spectral CT and FAPI PET-CT combined with AI in prediction of lymph node status in esophageal cancer
Time Frame: 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.
February 2025 - January 2030

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-527

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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