Multimodalitic Imaging in the N-stage of Lung Cancer

Sponsor

Peking University First Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05840094

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm of Lung	Drug: 18F-FDG Device: MR STIR Procedure: EBUS-TBNA	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: PET/CT+MR+EBUS

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

18F-FDG is injected intravenously with a dose of 0.1mCi/kg.

Device: MR STIR

The overall scanning time of MR is about 13min.

Procedure: EBUS-TBNA

Puncture about 20 times, 3 stitches in each group of enlarged lymph nodes, 1 stitch in the anterior, middle and posterior parts respectively

Experimental: PET/CT+EBUS

Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC

Drug: 18F-FDG

18F-FDG is injected intravenously with a dose of 0.1mCi/kg.

Procedure: EBUS-TBNA

Puncture about 20 times, 3 stitches in each group of enlarged lymph nodes, 1 stitch in the anterior, middle and posterior parts respectively

Experimental: MR+EBUS

Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC

Device: MR STIR

The overall scanning time of MR is about 13min.

Procedure: EBUS-TBNA

Puncture about 20 times, 3 stitches in each group of enlarged lymph nodes, 1 stitch in the anterior, middle and posterior parts respectively

Outcome Measures

Primary Outcome Measures

The diagnostic efficacy of18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA in the lymph node staging of NSCLC [1 year]
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.

Secondary Outcome Measures

The diagnostic efficacy of18F-FDG PET/CT combined with EBUS-TBNA in the lymph node staging of NSCLC [1 year]
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.
The diagnostic efficacy of18F-FDG PET/CT combined with MR STIR in the lymph node staging of NSCLC [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.