An observational study in Gastric Cancer Stage, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational
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.
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 222 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients diagnosed with gastric cancer by endoscopically biopsy will be considered for inclusion in the study.
Exclusion Criteria:
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 · Diagnostic Test: mpMRI examination
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 · Diagnostic Test: mpMRI examination
DECT examinations will be performed using a 192-slice CT scanner (SOMATOM, Force, Siemens, Forchheim, Germany).
The examinations were conducted on a 3-T MR scanner (MAGNETOM Skyra; Siemens Healthcare, Erlangen, Germany).
Diagnostic performance of DECT and mpMRI in tumor staging assessment
Accuracy for both imaging techniques in the prediction of tumor staging.
Time frame: 2 years
Diagnostic performance of DECT and mpMRI in tumor restaging assessment
Accuracy for both imaging techniques in the prediction of tumor restaging.
Time frame: 2 years
The kappa value
Inter-rater reliability of the DECT and mpMRI in tumor assessment
Time frame: 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.
Time frame: 4 years
Disease free survival (DFS)
Survival analysis: Radiologic data predicting DFS.
Time frame: 4 years
Overall survival (OS)
Survival analysis: Radiologic data predicting OS.
Time frame: 5 years
Likert scales 1-5
Qualitative image analysis of mpMRI in a supine and prone position
Time frame: 6 months
The signal-to-noise Ratio (SNR)
Quantitative image analysis of mpMRI in a supine and prone position.
Time frame: 6 months
Contrast-to-noise Ratio (CNR)
Quantitative image analysis of mpMRI in a supine and prone position.
Time frame: 6 months
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The First Affiliated Hospital with Nanjing Medical University