Multimodalitic Imaging in the N-stage of Lung Cancer

Neoplasm of Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05840094
• Other study ID #: LCN001
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: March 2023
• Source: Peking University First Hospital
• Contact: Meng Liu
• Phone: +86 13261995618
• Email: louisa_liu[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Neoplasm of Lung

Intervention

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

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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