MRI and CT in Gastroesophageal Junction or Upper Gastric Adenocarcinoma

NCT06640153 | Active Not Recruiting

• 1 other identifier: 2024-SR-587
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Accurate preoperative Siewert classification, precise assessment of the extent of esophageal involvement, and staging is crucial for determining the appropriate surgical approach and achieving negative resection margins. The purpose of this study is to investigate the diagnostic performance of the Multi-parametric magnetic resonance imaging (mpMRI) and computed tomography (CT) in gastroesophageal junction and upper gastric cancers.

Conditions

Gastric Cancer, Gastroesophageal Junction Cancer

Keywords

MR; CT; Adenocarcinoma of the Gastroesophageal Junction; Gastric Cancer

Outcome Measures

Primary Outcomes (3)

• Siewert classification

  Compare the findings of multiparametric MRI and CT in the Siewert classification (Types I, II, and III) against a histopathological reference standard, evaluating sensitivity, specificity, positive predictive value, and negative predictive value.

  2 years

• length of esophageal involvement

  The accuracy and AUC of length of esophageal involvement (not involved, 0-2cm, 2-3cm, 3-4cm, \>4cm) evaluated by CT and MRI.

  2 years

• Staging

  Compare the cancer stage (according to AJCC 8th edition TNM-classification) as determined by mpMRI compared to CT at primary staging and at restaging. The proportion of upgraded, downgraded, and right patients are determined.

  2 years

Secondary Outcomes (2)

• Survival time and recurrence time

  3 years

• The number of patients with complications

  Within 30 days after the day of operation

Study Arms (1)

Experimental: Gastroesophageal junction or upper gastric adenocarcinoma

Patients with biopsy verified gastroesophageal junction or upper gastric adenocarcinoma undergo mpMRI in addition to conventional CT imaging

Diagnostic Test: mpMRI

Interventions

mpMRI DIAGNOSTIC_TEST

Gastroesophageal junction or upper gastric adenocarcinoma patients undergo mpMRI at siewert classification, length of esophageal involvement, primary staging and restaging

Experimental: Gastroesophageal junction or upper gastric adenocarcinoma

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with gastroesophageal junction or upper gastric adenocarcinoma who are candidates for radical surgical intervention.

You may qualify if:

• patients with gastric cancer confirmed by preoperative gastroscopic biopsy;
• underwent standardized mpMRI and CT examination;
• patients with complete postoperative pathological data and pathological results of gastroesophageal Junction or upper gastric adenocarcinoma;

You may not qualify if:

• combined with other tumors;
• Clinical and imaging data were missing or could not meet the research needs;
• the location of lesions could not be determined;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: August 21, 2024
• Primary Completion: August 24, 2025
• Study Completion (Estimated): August 24, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)