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NCT Number: NCT05508126

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DECT examination

Diagnostic Test

DECT examinations will be performed using a 192-slice CT scanner (SOMATOM, Force, Siemens, Forchheim, Germany).

mpMRI examination

Diagnostic Test

The examinations were conducted on a 3-T MR scanner (MAGNETOM Skyra; Siemens Healthcare, Erlangen, Germany).

Primary outcomes

  1. 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. 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.

Secondary outcomes

  1. The kappa value

    Time frame: 2 years

    Inter-rater reliability of the DECT and mpMRI in tumor assessment

  2. 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.

  3. Disease free survival (DFS)

    Time frame: 4 years

    Survival analysis: Radiologic data predicting DFS.

  4. Overall survival (OS)

    Time frame: 5 years

    Survival analysis: Radiologic data predicting OS.

  5. Likert scales 1-5

    Time frame: 6 months

    Qualitative image analysis of mpMRI in a supine and prone position

  6. The signal-to-noise Ratio (SNR)

    Time frame: 6 months

    Quantitative image analysis of mpMRI in a supine and prone position.

  7. Contrast-to-noise Ratio (CNR)

    Time frame: 6 months

    Quantitative image analysis of mpMRI in a supine and prone position.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Aug 19, 2022
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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