Neoplasm of Lung
Conditions
Keywords
18F-FDG PET/CT, Neoplasm of Lung, EBUS-TBNA, MR STIR, NSCLC N-stage
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.
Interventions
DRUG18F-FDG
18F-FDG is injected intravenously with a dose of 0.1mCi/kg.
DEVICEMR STIR
The overall scanning time of MR is about 13min.
PROCEDUREEBUS-TBNA
Puncture about 20 times, 3 stitches in each group of enlarged lymph nodes, 1 stitch in the anterior, middle and posterior parts respectively
Sponsors
Peking University First Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactMeng Liu
Outcome results
None listed