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The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor

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ClinicalTrials.gov Identifier: NCT03881410
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

To use the shear-wave elastography to assist the transthoracic ultrasound-guided aspiration biopsy of peripheral lung tumor

  1. To identify the intra-tumor heterogeneity of elasticity
  2. To increase the diagnostic yield in ultrasound-guided transthoracic biopsy of subpleural pulmonary tumor

Condition or disease Intervention/treatment Phase
Lung Tumor Procedure: different types of ultrasound technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor: a Randomized Controlled Trial
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Lung Cancer

Arm Intervention/treatment
Experimental: Shear-wave elastography-guided Procedure: different types of ultrasound technique
Shear-wave elastography-guided or Convention ultrasound-guided

Active Comparator: Convention ultrasound-guided Procedure: different types of ultrasound technique
Shear-wave elastography-guided or Convention ultrasound-guided




Primary Outcome Measures :
  1. The diagnostic yield between two groups [ Time Frame: 6 months ]
    sensitivity, specificity, positive predictive value, and negative predictive value


Secondary Outcome Measures :
  1. Total times of the biopsy [ Time Frame: 1 day ]
    Total times of the biopsy

  2. Procedure duration [ Time Frame: 1 day ]
    Time duration

  3. Complication rate [ Time Frame: 1 day ]
    Complications like pneumothorax or hemothorax



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

(1) Patients with radiographic evidence of pulmonary lesions

Exclusion criteria:

  1. Age < 20 y/o
  2. Patients who cannot hold their breath for 5 seconds
  3. Inadequate shear-wave propagation of lung tumor

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): NCT03881410


Contacts
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Contact: Yao-Wen Kuo 0972651821 zorrokuo@ntuh.gov.tw

Sponsors and Collaborators
National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03881410     History of Changes
Other Study ID Numbers: 201812180RINA
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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