MRI and CT in Gastroesophageal Junction or Upper Gastric Adenocarcinoma

NCT06640153 — Active not recruiting, 100 participants, The First Affiliated Hospital with Nanjing Medical University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Preoperative Evaluation of Resectability in Gastroesophageal Junction and Upper Gastric Adenocarcinoma Utilizing Multi-Parametric MRI and CT Imaging.

RegistryNCT06640153
StatusActive not recruiting
Study typeObservational
Enrollment100 (Estimated)
SponsorThe First Affiliated Hospital with Nanjing Medical University (Other)
ConditionsGastric Cancer, Gastroesophageal Junction Cancer
InterventionsmpMRI (Diagnostic test)
Datesstart 2024-08-21, primary completion 2025-08-24 (estimated), completion 2027-08-24 (estimated), first posted 2024-10-15, last updated 2024-10-15
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Gastric Cancer, Gastroesophageal Junction Cancer All trials of mpMRI

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Experimental: Gastroesophageal junction or upper gastric adenocarcinomaDiagnostic Test: mpMRIPatients with biopsy verified gastroesophageal junction or upper gastric adenocarcinoma undergo mpMRI in addition to conventional CT imaging
  • mpMRI (Diagnostic test): Gastroesophageal junction or upper gastric adenocarcinoma patients undergo mpMRI at siewert classification, length of esophageal involvement, primary staging and restaging

+Outcome measures

Primary outcomes

  • 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.
  • 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.

Secondary outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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;

+Locations (1)

FacilityCityCountryStatus
The First Affiliated Hospital with Nanjing Medical UniversityNanjing, JiangsuChina

+Study documents