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Trial Title:
Multimodalitic Imaging in the N-stage of Lung Cancer
NCT ID:
NCT05840094
Condition:
Neoplasm of Lung
Conditions: Official terms:
Lung Neoplasms
Fluorodeoxyglucose F18
Conditions: Keywords:
18F-FDG PET/CT
Neoplasm of Lung
EBUS-TBNA
MR STIR
NSCLC N-stage
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-FDG
Description:
18F-FDG is injected intravenously with a dose of 0.1mCi/kg.
Arm group label:
PET/CT+EBUS
Arm group label:
PET/CT+MR+EBUS
Intervention type:
Device
Intervention name:
MR STIR
Description:
The overall scanning time of MR is about 13min.
Arm group label:
MR+EBUS
Arm group label:
PET/CT+MR+EBUS
Intervention type:
Procedure
Intervention name:
EBUS-TBNA
Description:
Puncture about 20 times, 3 stitches in each group of enlarged lymph nodes, 1 stitch in
the anterior, middle and posterior parts respectively
Arm group label:
MR+EBUS
Arm group label:
PET/CT+EBUS
Arm group label:
PET/CT+MR+EBUS
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Zip:
100034
Country:
China
Contact:
Last name:
Meng Liu
Phone:
13261995618
Email:
louisa_liu@bjmu.edu.cn
Start date:
May 1, 2023
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Peking University First Hospital
Agency class:
Other
Source:
Peking University First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05840094
