Diffusion Weighted Magnetic Resonance Imaging for Preoperative Staging in Gastric Adenocarcinoma Patients

February 28, 2017 updated by: Bezmialem Vakif University

Use of Diffusion Weighted Magnetic Resonance Imaging to Stage Gastric Adenocarcinoma Patients Preoperatively

Preoperative staging for gastric adenocarcinoma is an important procedure to detect advanced disease stateS for the patients in which the surgery may be unnecessary to perform. Although there are many imaging techniques for this purpose, sensitivity and specificity of these techniques still remains to be low.Preoperative detection of peritoneal carcinomatosis and involvement of lymph nodes beyond D2 may prevent surgical procedures.

Removal of the determined lymph nodes according to the type of the surgery is the accepted surgical method. However, accurate determination of malignant lymph nodes may prevent dissection of some groups of the lymph nodes. These findings may cause a new definition of gastric lymph node dissection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. proven endoscopic diagnosis of gastric adenocarcinoma
  2. for staging purposes, computed tomography for all patients
  3. evaluation of benign and malignant lymph nodes according to computed tomography findings and mapping of the lymph nodes
  4. to state precisely resectable patients according to computed tomography and anesthetic evaluation
  5. evaluation of benign and malignant lymph nodes according to diffusion weighted magnetic resonance imaging findings and mapping of the lymph nodes
  6. standard gastrectomy and D2 lymph node dissection
  7. mapping of the lymph nodes after taking the specimen out
  8. histopathological diagnosis of the lymph nodes and mapping
  9. comparison of the results taken from computed tomography, diffusion weighted magnetic resonance imaging and histopathological analysis

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

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

  • Turkey
      • Istanbul, Turkey, 34093
        • bezmialem vakif university faculty of medicine dept of general surgery

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • gastric adenocarcinoma proven by endoscopic biopsy;
  • application of both computed tomography and diffusion weighted magnetic resonance imaging;
  • standard gastrectomy and a D2 lymph node dissection;
  • desire to attend the study protocol

Exclusion Criteria:

  • preoperative neoadjuvant therapy;
  • metastatic disease;
  • undesired reaction to attend the study protocol

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: diffusion MRI
histopathology of lymph nodes diagnosed by diffusion weighted magnetic resonance imaging
Procedure: diffusion weighted magnetic resonance imaging
for diagnostic purposes, diffusion weighted magnetic resonance imaging in all patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of diffusion weighted magnetic resonance imaging to detect benign and malignant lymph nodes
Time Frame: one year
to compare the radiologic diagnosis of benign and malignant lymph nodes with histopathological diagnosis
one year

Collaborators and Investigators

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

Sponsor

Bezmialem Vakif 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

March 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 15, 2013

First Posted (Estimate)

February 18, 2013

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DWMRIGASTADENO

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.

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