Multimodalitic Imaging in the N-stage of Lung Cancer

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasm of Lung
• Intervention / Treatment: Drug: 18F-FDG; Device: MR STIR; Procedure: EBUS-TBNA

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meng Liu; Phone Number: +86 13261995618; Email: louisa_liu@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
      • Contact: Meng Liu; Phone Number: 13261995618; Email: louisa_liu@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: EBUS-TBNA; 18F-FDG PET/CT; Neoplasm of Lung; MR STIR; NSCLC N-stage
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: LCN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No