Multimodalitic Imaging in the N-stage of Lung Cancer

Peking University First Hospital100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Neoplasm of Lung

Interventions

18F-FDGDRUG

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

MR STIRDEVICE

The overall scanning time of MR is about 13min.

EBUS-TBNAPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 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.

Time frame: 1 year

Central Contacts

Meng Liu

CONTACT

+86 13261995618 louisa_liu@bjmu.edu.cn

Data from ClinicalTrials.gov

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