Multimodalitic Imaging in the N-stage of Lung Cancer

Study Overview
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Brief Summary
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This study aims to evaluate the diagnostic efficacy and differences between 18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA, 18F-FDG PET/CT combined with EBUS-TBNA, and MR STIR sequences combined with EBUS-TBNA - three types of multimodal imaging for assessing NSCLC N-stage, in order to select the best assessment protocol to guide treatment decisions and prognostic assessments.

Official Title
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A Prospective Study of the Predictive and Prognostic Value of Multimodalitic Imaging in the N-stage of Lung Cancer

Conditions
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Neoplasm of Lung

Intervention / Treatment
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* Drug: 18F-FDG
* Device: MR STIR
* Procedure: EBUS-TBNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy pathologically confirmed NSCLC, or clinically highly suspicious NSCLC (assessed as highly suspicious by the MDT team of this study); N1, N2, or N3 confined to the mediastinum and hilum, as assessed by imaging; Proposed systematic lymph node dissection without any treatment; Appropriate laboratory tests (serum tumor markers); All examination intervals ≤ 4 weeks; KPS score ≥ 50 (ECOG/WHO equivalent); Aged > 18 years; 8. Patients can fully understand and voluntarily participate in this trial and sign the informed consent; the examination can be completed independently. Exclusion Criteria: Contraindication to EBUS-TBNA operation; Presence or history of other malignancies within 10 years; Inability to understand the examination procedure or to cooperate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/CT+MR+EBUS<br>Subjects will receive 18F-FDG PET/CT and MR STIR sequence combined with EBUS-TBNA, to diagnose the N-stage of NSCLC | Drug: 18F-FDG<br>* 18F-FDG is injected intravenously with a dose of 0.1mCi/kg.<br>Device: MR STIR<br>* The overall scanning time of MR is about 13min.<br>Procedure: EBUS-TBNA<br>* Puncture about 20 times, 3 stitches in each group of enlarged lymph nodes, 1 stitch in the anterior, middle and posterior parts respectively<br>|
| Experimental: PET/CT+EBUS<br>Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC | Drug: 18F-FDG<br>* 18F-FDG is injected intravenously with a dose of 0.1mCi/kg.<br>Procedure: EBUS-TBNA<br>* Puncture about 20 times, 3 stitches in each group of enlarged lymph nodes, 1 stitch in the anterior, middle and posterior parts respectively<br>|
| Experimental: MR+EBUS<br>Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC | Device: MR STIR<br>* The overall scanning time of MR is about 13min.<br>Procedure: EBUS-TBNA<br>* Puncture about 20 times, 3 stitches in each group of enlarged lymph nodes, 1 stitch in the anterior, middle and posterior parts respectively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic efficacy of18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA in the lymph node staging of NSCLC | Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of three multimodal methods for diagnosing mediastinal lymph node staging in NSCLC based on patients. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic efficacy of18F-FDG PET/CT combined with EBUS-TBNA in the lymph node staging of NSCLC | Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of two multimodal methods for diagnosing mediastinal lymph node staging in NSCLC based on patients. | 1 year | 
| The diagnostic efficacy of18F-FDG PET/CT combined with MR STIR in the lymph node staging of NSCLC | Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of two multimodal methods for diagnosing mediastinal lymph node staging in NSCLC based on patients. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-FDG PET/CT, Neoplasm of Lung, EBUS-TBNA, MR STIR, NSCLC N-stage