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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

All patients diagnosed with gastric cancer by endoscopically biopsy will be considered for inclusion in the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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).

Treatment groups

222 Participants
are divided into 2 treatment groups
Group A: Primary staging group I2 interventions
Group B: Restaging group II2 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

The kappa value

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

Time frame
2 years
2

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
3

Disease free survival (DFS)

Survival analysis: Radiologic data predicting DFS.

Time frame
4 years
4

Overall survival (OS)

Survival analysis: Radiologic data predicting OS.

Time frame
5 years

Other outcomes

Sponsors and contacts

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