Multimodalitic Imaging in the N-stage of Lung Cancer

Not Applicable

Not yet recruiting

• Conditions: Neoplasm of Lung
• Interventions: Drug: 18F-FDG; Procedure: EBUS-TBNA; Device: MR STIR

• Registration Number: NCT05840094
• Lead Sponsor: Peking University First Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-04-21
• Last Update Submitted: 2023-04-21
• Study Start: 2023-05-01
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/CT+EBUS	EBUS-TBNA	Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC
PET/CT+MR+EBUS	MR STIR	Subjects will receive 18F-FDG PET/CT and MR STIR sequence combined with EBUS-TBNA, to diagnose the N-stage of NSCLC
MR+EBUS	MR STIR	Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC
PET/CT+MR+EBUS	EBUS-TBNA	Subjects will receive 18F-FDG PET/CT and MR STIR sequence combined with EBUS-TBNA, to diagnose the N-stage of NSCLC
MR+EBUS	EBUS-TBNA	Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC
PET/CT+MR+EBUS	18F-FDG	Subjects will receive 18F-FDG PET/CT and MR STIR sequence combined with EBUS-TBNA, to diagnose the N-stage of NSCLC
PET/CT+EBUS	18F-FDG	Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China