Multi-parametric MRI and Dual-energy CT in Patients of Gastric Cancer

August 17, 2022 updated by: The First Affiliated Hospital with Nanjing Medical University

Diagnostic Accuracy of Multi-parametric MRI and Dual-energy CT in Gastric Cancer: a Paired Validating Confirmatory Study

Accurate preoperative staging of gastric cancer is of major importance for guiding therapeutic decision-making, preventing both under- and over-treatment. The purpose of this study is to investigate the diagnostic performance of the Multi-parametric magnetic resonance imaging (mpMRI) and dual-energy computed tomography (DECT) in gastric cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is the leading cause of cancer-related death worldwide. The therapeutic approach to gastric cancer is strongly dependent on preoperative stage. The crucial role of gastric cancer imaging lies in implementing individualized treatment regimens according to various stages of tumor.

CT scanning has been recommended as the first-line image modality for preoperative evaluation of gastric cancer by the 8th AJCC staging manual. However, for traditional CT, the accuracy of staging is highly variable and the sensitivity of early gastric cancer detection is relatively low. Recently, DECT has been increasingly used in clinical practice due to its powerful post-processing technique. A recent small sample study showed that monoenergetic images at 40 KeV improved lesion depiction and higher T stage accuracy for gastric cancer. Therefore, this study chose DECT instead of traditional CT to explore the diagnostic performance in preoperative staging.

Historically, the role of MRI in gastric cancer has been limited, and the guidelines have not yet recommended MRI as a first-line examination scheme. But with the continuous technical improvements for abdominal imaging (e.g. breath-hold sequences and high Resolution diffusion-weighted imaging (DWI), free-breathing dynamic contrast-enhanced (DCE) sequence), mpMRI has become a promising imaging technology. In addition, given the advantages of non-radiation, non-invasiveness, and excellent soft tissue contrast, mpMRI may be more suitable for neoadjuvant therapy patients who require multiple evaluations.

Patients with gastric cancer confirmed by endoscopic biopsy will be prospectively included in this study. Patients undergo both mpMRI and DECT at baseline to stage the primary tumor, regional lymph nodes, and to rule out distant sites of disease. The interval between mpMRI and DECT examinations should not exceed 7 days. All patients will be treated according to standard practice in our institution. Patients receiving neoadjuvant chemotherapy will undergo mpMRI and DECT scan again for restaging. The postoperative pathology results of these two examination methods were prospectively collected, and their efficacy was calculated according to the reference standard. After completion of study intervention, patients are followed up periodically.

Study Type

Observational

Enrollment (Anticipated)

222

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
      • Nanjing, China, 210029
        • Recruiting
        • Yu-Dong Zhang
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients diagnosed with gastric cancer by endoscopically biopsy will be considered for inclusion in the study.

Description

Inclusion Criteria:

  • Consecutive patients with preoperative pathologically confirmed GC by endoscopy and preoperative imaging data (DECT/mpMRI) were included.
  • No contraindications for CT/MRI examination
  • Written informed consent

Exclusion Criteria:

  • Patients with a history of previous therapy.
  • Patients with recurrent gastric cancer
  • Patients with a history of severe allergy to contrast agents
  • Patients with imaging artefacts affect the evaluation

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary staging group I
All patients will be treated according to standard practice. Patients in group I are patients that will be stratified for radical gastrectomy or endoscopic resection. Group I will undergo only a primary staging. All patients will take DECT and mpMRI examination within 1 week before surgery.
Diagnostic test: DECT examination
DECT examinations will be performed using a 192-slice CT scanner (SOMATOM, Force, Siemens, Forchheim, Germany).
Diagnostic test: mpMRI examination
The examinations were conducted on a 3-T MR scanner (MAGNETOM Skyra; Siemens Healthcare, Erlangen, Germany).
Restaging group II

Patients in group II are patients that will be stratified for neoadjuvant chemotherapy.

Group II will undergo a primary staging (DECT and mpMRI) and 1-2 times restaging (DECT and mpMRI).
Diagnostic test: DECT examination
DECT examinations will be performed using a 192-slice CT scanner (SOMATOM, Force, Siemens, Forchheim, Germany).
Diagnostic test: mpMRI examination
The examinations were conducted on a 3-T MR scanner (MAGNETOM Skyra; Siemens Healthcare, Erlangen, Germany).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of DECT and mpMRI in tumor staging assessment
Time Frame: 2 years
Accuracy for both imaging techniques in the prediction of tumor staging.
2 years
Diagnostic performance of DECT and mpMRI in tumor restaging assessment
Time Frame: 2 years
Accuracy for both imaging techniques in the prediction of tumor restaging.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The kappa value
Time Frame: 2 years
Inter-rater reliability of the DECT and mpMRI in tumor assessment
2 years
Predictive value of DECT and mpMRI after the neoadjuvant treatment for pathologic response
Time Frame: 4 years
Pathological tumour regression grading (Mandard criterion): from 1 to 5 grading.
4 years
Disease free survival (DFS)
Time Frame: 4 years
Survival analysis: Radiologic data predicting DFS.
4 years
Overall survival (OS)
Time Frame: 5 years
Survival analysis: Radiologic data predicting OS.
5 years
Likert scales 1-5
Time Frame: 6 months
Qualitative image analysis of mpMRI in a supine and prone position
6 months
The signal-to-noise Ratio (SNR)
Time Frame: 6 months
Quantitative image analysis of mpMRI in a supine and prone position.
6 months
Contrast-to-noise Ratio (CNR)
Time Frame: 6 months
Quantitative image analysis of mpMRI in a supine and prone position.
6 months

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-SR-475

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.

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