Electromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer
Electromagnetic Navigation Guided Versus CT-guided Transthoracic Needle Aspiration (TTNA) in the Diagnosis of Early Peripheral Lung Cancer, a Randomized Open Label Trial
1 other identifier
interventional
322
1 country
1
Brief Summary
The purpose of this study is to compare Electromagnetic navigation guided with CT-guided transthoracic needle aspiration (TTNA) in the diagnosis of pulmonary peripheral nodule. Primary endpoints：Diagnostic rate Secondary endpoints：operating time、adverse events Study design: Multicenter、randomized、open lebel
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lung-cancer
Started Jan 2019
Shorter than P25 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 8, 2019
CompletedFirst Posted
Study publicly available on registry
January 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedJanuary 14, 2019
January 1, 2019
12 months
January 8, 2019
January 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic rate
18 months
Secondary Outcomes (2)
Operating time
18 months
Adverse events
18 months
Study Arms (2)
Electromagnetic Navigation group
EXPERIMENTALElectromagnetic Navigation Guided Transthoracic Needle Aspiration
CT group
ACTIVE COMPARATORCT-guided Transthoracic Needle Aspiration
Interventions
Patients in this group will receive electromagnetic navigation guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule
Patients in this group will receive CT guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule
Eligibility Criteria
You may qualify if:
- Patients with 0.8-3 cm, high-risk pulmonary peripheral nodules that need biopsy for pathological diagnosis;
- Patients who are older than 18 year-old;
- Patients voluntarily join the study and give written informed consent for the study.
You may not qualify if:
- Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
- Large blood vessels or important structures on the puncture path of peripheral lung tumors；
- Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Chest Hospitallead
- Air Force Military Medical University, Chinacollaborator
- Third Military Medical Universitycollaborator
Study Sites (1)
Shanghai Chest hospital
Shanghai, Shanghai Municipality, 200030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hua Zhong, Phd，MD
Shanghai Chest Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Hua Zhong
Study Record Dates
First Submitted
January 8, 2019
First Posted
January 14, 2019
Study Start
January 1, 2019
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
January 14, 2019
Record last verified: 2019-01