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

NCT01794026 | Completed Early Phase 1

• 1 other identifier: DWMRIGASTADENO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Adenocarcinoma

Keywords

diffusion weighted; magnetic resonance imaging; surgery; histopathology

Outcome Measures

Primary Outcomes (1)

• efficacy of diffusion weighted magnetic resonance imaging to detect benign and malignant lymph nodes

  to compare the radiologic diagnosis of benign and malignant lymph nodes with histopathological diagnosis

  one year

Study Arms (1)

diffusion MRI

EXPERIMENTAL

histopathology of lymph nodes diagnosed by diffusion weighted magnetic resonance imaging

Procedure: diffusion weighted magnetic resonance imaging

Interventions

diffusion weighted magnetic resonance imaging PROCEDURE

for diagnostic purposes, diffusion weighted magnetic resonance imaging in all patients

diffusion MRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University Faculty of Medicine Dept of General Surgery

Istanbul, 34093, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: February 18, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 1, 2017

Record last verified: 2013-12

Locations

TU (1)