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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Gastric Cancer Stage

Intervention / Treatment
-----------------
* Diagnostic Test: DECT examination
* Diagnostic Test: mpMRI examination


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary staging group I<br>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<br>* DECT examinations will be performed using a 192-slice CT scanner (SOMATOM, Force, Siemens, Forchheim, Germany).<br>Diagnostic Test: mpMRI examination<br>* The examinations were conducted on a 3-T MR scanner (MAGNETOM Skyra; Siemens Healthcare, Erlangen, Germany).<br>|
| Restaging group II<br>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<br>* DECT examinations will be performed using a 192-slice CT scanner (SOMATOM, Force, Siemens, Forchheim, Germany).<br>Diagnostic Test: mpMRI examination<br>* The examinations were conducted on a 3-T MR scanner (MAGNETOM Skyra; Siemens Healthcare, Erlangen, Germany).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of DECT and mpMRI in tumor staging assessment | Accuracy for both imaging techniques in the prediction of tumor staging. | 2 years | 
| Diagnostic performance of DECT and mpMRI in tumor restaging assessment | 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 | 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 | Pathological tumour regression grading (Mandard criterion): from 1 to 5 grading. | 4 years | 
| Disease free survival (DFS) | Survival analysis: Radiologic data predicting DFS. | 4 years | 
| Overall survival (OS) | Survival analysis: Radiologic data predicting OS. | 5 years | 
| Likert scales 1-5 | Qualitative image analysis of mpMRI in a supine and prone position | 6 months | 
| The signal-to-noise Ratio (SNR) | Quantitative image analysis of mpMRI in a supine and prone position. | 6 months | 
| Contrast-to-noise Ratio (CNR) | Quantitative image analysis of mpMRI in a supine and prone position. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Computed Tomography, Magnetic Resonance Imaging