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

January 10, 2019 updated by: Hua Zhong, Shanghai Chest Hospital

Electromagnetic Navigation Guided Versus CT-guided Transthoracic Needle Aspiration (TTNA) in the Diagnosis of Early Peripheral Lung Cancer, a Randomized Open Label Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

322

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic rate
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 18 months
18 months
Operating time
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Collaborators

Third Military Medical University
Air Force Military Medical University, China

Investigators

  • Principal Investigator: Hua Zhong, Phd，MD, Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

January 8, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chest 010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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