Multimodalitic Imaging in the N-stage of Lung Cancer

NCT ID: NCT05840094

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasm of Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET/CT+MR+EBUS

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

Group Type EXPERIMENTAL

18F-FDG

Intervention Type DRUG

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

MR STIR

Intervention Type DEVICE

The overall scanning time of MR is about 13min.

EBUS-TBNA

Intervention Type PROCEDURE

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

PET/CT+EBUS

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

Group Type EXPERIMENTAL

18F-FDG

Intervention Type DRUG

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

EBUS-TBNA

Intervention Type PROCEDURE

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

MR+EBUS

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

Group Type EXPERIMENTAL

MR STIR

Intervention Type DEVICE

The overall scanning time of MR is about 13min.

EBUS-TBNA

Intervention Type PROCEDURE

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

Interventions

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18F-FDG

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

Intervention Type DRUG

MR STIR

The overall scanning time of MR is about 13min.

Intervention Type DEVICE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Meng Liu

Role: CONTACT

+86 13261995618

Facility Contacts

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Meng Liu

Role: primary

13261995618

Other Identifiers

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LCN001

Identifier Type: -

Identifier Source: org_study_id

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