Clinical trial NCT05508126: Multi-parametric MRI and Dual-energy CT in Patients of Gastric Cancer
Official title: Diagnostic Accuracy of Multi-parametric MRI and Dual-energy CT in Gastric Cancer: a Paired Validating Confirmatory Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer Stage
Keywords: Computed Tomography
Magnetic Resonance Imaging
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed with gastric cancer by endoscopically biopsy will be considered for inclusion in the study.

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.

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

Primary outcomes:
measure: Diagnostic performance of DECT and mpMRI in tumor staging assessment
timeFrame: 2 years
measure: Diagnostic performance of DECT and mpMRI in tumor restaging assessment
timeFrame: 2 years
Secondary outcomes:
measure: The kappa value
timeFrame: 2 years
measure: Predictive value of DECT and mpMRI after the neoadjuvant treatment for pathologic response
timeFrame: 4 years
measure: Disease free survival (DFS)
timeFrame: 4 years
measure: Overall survival (OS)
timeFrame: 5 years
measure: Likert scales 1-5
timeFrame: 6 months
measure: The signal-to-noise Ratio (SNR)
timeFrame: 6 months
measure: Contrast-to-noise Ratio (CNR)
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Yu-Dong Zhang
Study officials:
References:
citation: Zhen Y, Xie Q, Liu L. Diagnostic Value of Spiral CT and Magnetic Resonance Imaging Scanning in Gastric Cancer and Precancerous Lesions. Scanning. 2022 May 23;2022:3627385. doi: 10.1155/2022/3627385. eCollection 2022.
citation: Giganti F, Orsenigo E, Arcidiacono PG, Nicoletti R, Albarello L, Ambrosi A, Salerno A, Esposito A, Petrone MC, Chiari D, Staudacher C, Del Maschio A, De Cobelli F. Preoperative locoregional staging of gastric cancer: is there a place for magnetic resonance imaging? Prospective comparison with EUS and multidetector computed tomography. Gastric Cancer. 2016 Jan;19(1):216-25. doi: 10.1007/s10120-015-0468-1. Epub 2015 Jan 23.
citation: Borggreve AS, Goense L, Brenkman HJF, Mook S, Meijer GJ, Wessels FJ, Verheij M, Jansen EPM, van Hillegersberg R, van Rossum PSN, Ruurda JP. Imaging strategies in the management of gastric cancer: current role and future potential of MRI. Br J Radiol. 2019 May;92(1097):20181044. doi: 10.1259/bjr.20181044. Epub 2019 Mar 5.