MRI and CT in Gastroesophageal Junction or Upper Gastric Adenocarcinoma

Active, not recruiting

• Conditions: Gastric Cancer, Gastroesophageal Junction Cancer

• Registration Number: NCT06640153
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Despite a continuous decline in the incidence of gastric cancer in recent years, the morbidity and mortality rates associated with the gastroesophageal junction and upper gastric cancers remain elevated. Consequently, it is imperative to develop more refined and individualized precision strategies for screening, diagnosis, surgical intervention, and comprehensive treatment. Due to the unique anatomical location, considerable debate exists regarding the critical aspects of its surgical management in clinical practice. Multiparametric MRI offers significant anatomical benefits due to its high soft tissue resolution, and its functional imaging capabilities present promising applications. With advancements in abdominal imaging technology, novel techniques such as high-order diffusion imaging and compressed sensing technology have facilitated high-resolution MRI of the stomach during free breathing, which is now implemented in clinical practice. Prior research has demonstrated that individualized gastric MRI scanning consistently yields superior image quality, and MRI provides greater accuracy than CT in preoperative staging assessments. Nonetheless, the comparative study of MRI and CT in patients with gastroesophageal junction and upper gastric cancers remains to be elucidated.

Study Timeline

• Study Start: 2024-08-21
• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-08-24
• Study Completion: 2027-08-24

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Staging	2 years	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.
Siewert classification	2 years	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.
length of esophageal involvement	2 years	The accuracy and AUC of length of esophageal involvement (not involved, 0-2cm, 2-3cm, 3-4cm, \>4cm) evaluated by CT and MRI.

Secondary Outcome Measures

Name	Time	Method
Survival time and recurrence time	3 years	3-year overall survival; 1-year and 3-year recurrence free survival
The number of patients with complications	Within 30 days after the day of operation	The morbidity and mortality rates within 30 days after the day of operation

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China