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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03802266
• Other study ID #: Chest 010
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2019
• Source: Shanghai Chest Hospital
• Contact: Hua Zhong, Phd,MD
• Phone: 13818200560
• Email: eddiedong8[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 322
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Chest hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Chest Hospital	Fourth Military Medical University, Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic rate		18 months
Secondary	Operating time		18 months
Secondary	Adverse events		18 months