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NCT Number: NCT06640153

MRI and CT in Gastroesophageal Junction or Upper Gastric Adenocarcinoma

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

mpMRI

Diagnostic Test

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

Primary outcomes

  1. Siewert classification

    Time frame: 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.

  2. length of esophageal involvement

    Time frame: 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.

  3. Staging

    Time frame: 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

  1. Survival time and recurrence time

    Time frame: 3 years

    3-year overall survival

    1-year and 3-year recurrence free survival

  2. The number of patients with complications

    Time frame: Within 30 days after the day of operation

    The morbidity and mortality rates within 30 days after the day of operation

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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