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

Gastric Cancer Stage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05508126
• Other study ID #: 2021-SR-475
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 222
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer Stage
• Stomach Neoplasms

Intervention

Diagnostic Test:
• DECT examination
DECT examinations will be performed using a 192-slice CT scanner (SOMATOM, Force, Siemens, Forchheim, Germany).
• mpMRI examination
The examinations were conducted on a 3-T MR scanner (MAGNETOM Skyra; Siemens Healthcare, Erlangen, Germany).

Locations

Country	Name	City	State
China	Yu-Dong Zhang	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of DECT and mpMRI in tumor staging assessment	Accuracy for both imaging techniques in the prediction of tumor staging.	2 years
Primary	Diagnostic performance of DECT and mpMRI in tumor restaging assessment	Accuracy for both imaging techniques in the prediction of tumor restaging.	2 years
Secondary	The kappa value	Inter-rater reliability of the DECT and mpMRI in tumor assessment	2 years
Secondary	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
Secondary	Disease free survival (DFS)	Survival analysis: Radiologic data predicting DFS.	4 years
Secondary	Overall survival (OS)	Survival analysis: Radiologic data predicting OS.	5 years
Secondary	Likert scales 1-5	Qualitative image analysis of mpMRI in a supine and prone position	6 months
Secondary	The signal-to-noise Ratio (SNR)	Quantitative image analysis of mpMRI in a supine and prone position.	6 months
Secondary	Contrast-to-noise Ratio (CNR)	Quantitative image analysis of mpMRI in a supine and prone position.	6 months