MRI and CT in Gastroesophageal Junction or Upper Gastric Adenocarcinoma

October 10, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • The First Affiliated Hospital with Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Gastroesophageal junction or upper gastric adenocarcinoma patients undergo mpMRI at siewert classification, length of esophageal involvement, primary staging and restaging

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years
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.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survival time and recurrence time
Time Frame: 3 years

3-year overall survival

1-year and 3-year recurrence free survival
3 years
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
Within 30 days after the day of operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 24, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-SR-587

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer, Gastroesophageal Junction Cancer

Clinical Trials on mpMRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings