Neoplasm of LungNCT05840094
Multimodalitic Imaging in the N-stage of Lung Cancer
A study testing 18F-FDG, MR STIR and EBUS-TBNA in people with Neoplasm of Lung, run by Peking University First Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasm of Lung
- What is being tested?
- 18F-FDG, MR STIR and EBUS-TBNA
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Contraindication to EBUS-TBNA operation;
- Presence or history of other malignancies within 10 years;
- Inability to understand the examination procedure or to cooperate.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Meng Liu, 13261995618, louisa_liu@bjmu.edu.cn
About this study
Official title: A Prospective Study of the Predictive and Prognostic Value of Multimodalitic Imaging in the N-stage of Lung Cancer
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.
- Conditions
- Neoplasm of Lung
- Being tested
- 18F-FDG, MR STIR, EBUS-TBNA
- Keywords
- 18F-FDG PET/CT, Neoplasm of Lung, EBUS-TBNA, MR STIR, NSCLC N-stage
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDrug
18F-FDG is injected intravenously with a dose of 0.1mCi/kg.
MR STIRDevice
The overall scanning time of MR is about 13min.
EBUS-TBNAProcedure or surgery
Puncture about 20 times, 3 stitches in each group of enlarged lymph nodes, 1 stitch in the anterior, middle and posterior parts respectively
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: 18F-FDG; Device: MR STIR; Procedure: EBUS-TBNA |
| PET/CT+EBUS | Experimental | Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC Receives: Drug: 18F-FDG; Procedure: EBUS-TBNA |
| MR+EBUS | Experimental | Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC Receives: Device: MR STIR; Procedure: EBUS-TBNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm of LungStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840094
- Sponsor's protocol ID
- LCN001
- Status last verified
- Mar 2023
- First submitted
- 21 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Predictive and Prognostic Value of Multimodalitic Imaging in the N-stage of Lung Cancer
- ClinicalTrials.gov ID
- NCT05840094
- Acronym / sponsor ID
- LCN001
- Conditions
- Neoplasm of Lung
- Keywords
- 18F-FDG PET/CT, Neoplasm of Lung, EBUS-TBNA, MR STIR, NSCLC N-stage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PET/CT+MR+EBUS | Experimental | Drug: 18F-FDG, Device: MR STIR, Procedure: EBUS-TBNASubjects will receive 18F-FDG PET/CT and MR STIR sequence combined with EBUS-TBNA, to diagnose the N-stage of NSCLC |
| PET/CT+EBUS | Experimental | Drug: 18F-FDG, Procedure: EBUS-TBNASubjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC |
| MR+EBUS | Experimental | Device: MR STIR, Procedure: EBUS-TBNASubjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- Contraindication to EBUS-TBNA operation;
- Presence or history of other malignancies within 10 years;
- Inability to understand the examination procedure or to cooperate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG18F-FDG is injected intravenously with a dose of 0.1mCi/kg. | Drug | PET/CT+EBUS, PET/CT+MR+EBUS |
| MR STIRThe overall scanning time of MR is about 13min. | Device | MR+EBUS, PET/CT+MR+EBUS |
| EBUS-TBNAPuncture about 20 times, 3 stitches in each group of enlarged lymph nodes, 1 stitch in the anterior, middle and posterior parts respectively | Procedure or surgery | MR+EBUS, PET/CT+EBUS, PET/CT+MR+EBUS |
Primary outcome
The diagnostic efficacy of18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA in the lymph node staging of NSCLC
Time frame: 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.
2 secondary outcomes
The diagnostic efficacy of18F-FDG PET/CT combined with EBUS-TBNA in the lymph node staging of NSCLC
Time frame: 1 year
The diagnostic efficacy of18F-FDG PET/CT combined with MR STIR in the lymph node staging of NSCLC
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG, MR STIR and EBUS-TBNA in people with Neoplasm of Lung, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng Liu (+86 13261995618, louisa_liu@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic efficacy of18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA in the lymph node staging of NSCLC (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.