Back to resultsElectromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electromagnetic Navigation guided transthoracic needle aspiration
CT-guided Transthoracic Needle Aspiration
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Shanghai Chest hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electromagnetic Navigation group
CT group
Arm Description
Electromagnetic Navigation Guided Transthoracic Needle Aspiration
CT-guided Transthoracic Needle Aspiration
Outcomes
Primary Outcome Measures
Diagnostic rate
Secondary Outcome Measures
Operating time
Adverse events
Full Information
NCT ID
NCT03802266
First Posted
January 8, 2019
Last Updated
January 10, 2019
Sponsor
Shanghai Chest Hospital
Collaborators
Air Force Military Medical University, China, Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03802266
Brief Title
Electromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer
Official Title
Electromagnetic Navigation Guided Versus CT-guided Transthoracic Needle Aspiration (TTNA) in the Diagnosis of Early Peripheral Lung Cancer, a Randomized Open Label Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
Collaborators
Air Force Military Medical University, China, Third Military Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
322 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electromagnetic Navigation group
Arm Type
Experimental
Arm Description
Electromagnetic Navigation Guided Transthoracic Needle Aspiration
Arm Title
CT group
Arm Type
Active Comparator
Arm Description
CT-guided Transthoracic Needle Aspiration
Intervention Type
Device
Intervention Name(s)
Electromagnetic Navigation guided transthoracic needle aspiration
Intervention Description
Patients in this group will receive electromagnetic navigation guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule
Intervention Type
Device
Intervention Name(s)
CT-guided Transthoracic Needle Aspiration
Intervention Description
Patients in this group will receive CT guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule
Primary Outcome Measure Information:
Title
Diagnostic rate
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Operating time
Time Frame
18 months
Title
Adverse events
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Zhong, Phd，MD
Phone
13818200560
Email
eddiedong8@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua Zhong, Phd，MD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Zhong, MD,PhD
Phone
86-21-22200000
Ext
3902
Email
eddiedong8@hotmail.com
First Name & Middle Initial & Last Name & Degree
Shuhui Cao, MD
Phone
86-21-22200000
Ext
3909
Email
caosh1994@163.com
12. IPD Sharing Statement
Learn more about this trial
Electromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer
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