NCT05840094

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 3, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

April 21, 2023

Last Update Submit

April 21, 2023

Conditions

Neoplasm of Lung

Keywords

18F-FDG PET/CTNeoplasm of LungEBUS-TBNAMR STIRNSCLC N-stage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The diagnostic efficacy of18F-FDG PET/CT combined with EBUS-TBNA in the lymph node staging of NSCLC

    1 year

  • The diagnostic efficacy of18F-FDG PET/CT combined with MR STIR in the lymph node staging of NSCLC

    1 year

Study Arms (3)

PET/CT+MR+EBUS

EXPERIMENTAL

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

Drug: 18F-FDGDevice: MR STIRProcedure: EBUS-TBNA

PET/CT+EBUS

EXPERIMENTAL

Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC

Drug: 18F-FDGProcedure: EBUS-TBNA

MR+EBUS

EXPERIMENTAL

Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC

Device: MR STIRProcedure: EBUS-TBNA

Interventions

18F-FDGDRUG

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

PET/CT+EBUSPET/CT+MR+EBUS
MR STIRDEVICE

The overall scanning time of MR is about 13min.

MR+EBUSPET/CT+MR+EBUS
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

MR+EBUSPET/CT+EBUSPET/CT+MR+EBUS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Contraindication to EBUS-TBNA operation;
  • Presence or history of other malignancies within 10 years;
  • Inability to understand the examination procedure or to cooperate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Central Study Contacts

Meng Liu

CONTACT

+86 13261995618louisa_liu@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 3, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

May 3, 2023

Record last verified: 2023-03

Locations

CN(1)