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Electromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802266
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
Fourth Military Medical University
Third Military Medical University
Information provided by (Responsible Party):
Hua Zhong, Shanghai Chest Hospital

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


Condition or disease Intervention/treatment Phase
Lung Cancer Device: Electromagnetic Navigation guided transthoracic needle aspiration Device: CT-guided Transthoracic Needle Aspiration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electromagnetic Navigation group
Electromagnetic Navigation Guided Transthoracic Needle Aspiration
Device: Electromagnetic Navigation guided transthoracic needle aspiration
Patients in this group will receive electromagnetic navigation guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule

Active Comparator: CT group
CT-guided Transthoracic Needle Aspiration
Device: CT-guided Transthoracic Needle Aspiration
Patients in this group will receive CT guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule




Primary Outcome Measures :
  1. Diagnostic rate [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Operating time [ Time Frame: 18 months ]
  2. Adverse events [ Time Frame: 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with 0.8-3 cm, high-risk pulmonary peripheral nodules that need biopsy for pathological diagnosis;
  2. Patients who are older than 18 year-old;
  3. Patients voluntarily join the study and give written informed consent for the study.

Exclusion Criteria:

  1. Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
  2. Large blood vessels or important structures on the puncture path of peripheral lung tumors;
  3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802266


Contacts
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Contact: Hua Zhong, Phd,MD 13818200560 eddiedong8@hotmail.com

Locations
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China, Shanghai
Shanghai Chest hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Hua Zhong, MD,PhD    86-21-22200000 ext 3902    eddiedong8@hotmail.com   
Contact: Shuhui Cao, MD    86-21-22200000 ext 3909    caosh1994@163.com   
Sponsors and Collaborators
Shanghai Chest Hospital
Fourth Military Medical University
Third Military Medical University
Investigators
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Principal Investigator: Hua Zhong, Phd,MD Shanghai Chest Hospital
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Responsible Party: Hua Zhong, Professor Hua Zhong, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT03802266    
Other Study ID Numbers: Chest 010
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases