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Not yet recruitingNCT06818214Updated Feb 10, 2025

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

An observational study in Esophageal Cancer, sponsored by Henan Cancer Hospital. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by Henan Cancer Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Esophageal Cancer
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In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 400 is above the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • the group with lymph node metastasis in esophageal cancer
  • the group without lymph node metastasis in esophageal cancer
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What researchers measure

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.

    Time frame: February 2025 - January 2030

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06818214
Lead sponsor
Henan Cancer Hospital
Responsible party
Qujinrong (Dr., Henan Cancer Hospital) — Principal investigator
First posted
Feb 10, 2025
Start date
Feb 2025 (estimated)
Primary completion
Jan 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Feb 10, 2025

Study contacts

Jinrong Qu
Contact
qjryq@126.com
(86) 0371-65587595

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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