Significance of Ultrasound Elastography in Lymph Node

NCT03391557 | Unknown DMC

• 1 other identifier: YL20160713-020
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background and Objectives: Elastography can reflect the difference of tissue hardness, which helps to identify the difference of hardness between benign and malignant tissues. The aim of this study was to evaluate the value of endobronchial ultrasound elastography in the differential diagnosis of benign and malignant intrathoracic lymph nodes. Materials and Methods: A total of 42 patients with intrathoracic lymphadenopathy required for EBUS-TBNA examination were prospectively enrolled. Firstly, All patients were evaluated by enhanced chest CT examination,the EBUS B-mode ultrasound and EBUS-guided elastography before EBUS-TBNA.Then, the investigators evaluated every lymph node by describing the characteristics of the CT image (Short diameter, texture, shape, boundary ,mean CT value), B-mode ultrasound (short diameter, echo characteristic, shape, boundary) and elastography (image type, grading score, strain rate, blue area ratio). Finally, the pathological results were used as the gold standard. the investigators compare the characteristics of the 3 evaluating methods alone and in combination between benign and malignant lymph nodes.

Conditions

Lung Cancer

Keywords

Elastography; Lymph node; Diagnosis

Outcome Measures

Primary Outcomes (1)

• The echo characteristic of the B-mode ultrasound of lymph nodes.

  echo characteristic(hypoechoic or not hypoechoic, homogeneous or not)

  10 minutes

Secondary Outcomes (7)

• The shape of the B-mode ultrasound of lymph nodes.

  10 minutes

• The boundary of the B-mode ultrasound of lymph nodes.

  10 minutes

• The short diameter of the B-mode ultrasound of lymph nodes.

  10 minutes

• The image type of the elastography of lymph nodes.

  10 minutes

• The strain ratio of the elastography of lymph nodes.

  10 minutes

Other Outcomes (5)

• The short diameter of the enhanced chest computed tomography of lymph nodes.

  30 minutes

• The texture of the enhanced chest computed tomography of lymph nodes.

  6 minutes

• The shape of the enhanced chest computed tomography of lymph nodes.

  6 minutes

Study Arms (1)

Patients with the UE examination

EXPERIMENTAL

Patients with enlarged intrathoracic lymph nodes(≥1cm) and/or 18-FDG high uptake (SUV Max \> 2.5) without bleeding tendency, abnormal coagulation function and serious cardiac dysfunction were finally selected.

Diagnostic Test: UE

Interventions

UE DIAGNOSTIC_TEST

All patients were examined by enhanced chest computed tomography (CT), the B-mode ultrasound and endobronchial ultrasound (EBUS)guided elastography before EBUS-TBNA. Each lymph node was assessed by describing the characteristics of the CT image (short diameter, texture, shape, boundary, mean CT value), B-mode ultrasound (short diameter, echo characteristic, shape, boundary) and ultrasound elastography (image type, grading score, strain rate, blue area ratio).

Also known as: Ultrasound Elastography

Patients with the UE examination

Eligibility Criteria

• Age: 27 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have enlarged intrathoracic lymph nodes(≥1cm) evaluated by chest enhanced CT and/or 18-FDG high uptake (SUV Max \> 2.5) evaluated by 18-FDG PET-CT.
• Patients who are willing to undergo electronic bronchoscopy and agreed to take TBNA and EBUS-TBNA for pathology.

You may not qualify if:

• There is a contraindication of electronic bronchoscopy: activity of hemoptysis, hypertension and arrhythmia, recent myocardial infarction or unstable angina pectoris attacks, serious heart and lung dysfunction, bleeding tendency which cannot be corrected, serious obstruction of superior vena cava syndrome, suspected aortic aneurysm, multiple pulmonary bullous,the body condition is extremely exhaustion, the pregnant or lactation period women, the infected wound deferred, uncontrollable mental illness.
• Patients who are not willing to accept electronic bronchoscopy.

Sponsors & Collaborators

• Fangsurong: lead
• Johns Hopkins University: collaborator

Related Publications (12)

• Ophir J, Cespedes I, Ponnekanti H, Yazdi Y, Li X. Elastography: a quantitative method for imaging the elasticity of biological tissues. Ultrason Imaging. 1991 Apr;13(2):111-34. doi: 10.1177/016173469101300201.

  PMID: 1858217 BACKGROUND

• Saftoiu A, Vilman P. Endoscopic ultrasound elastography-- a new imaging technique for the visualization of tissue elasticity distribution. J Gastrointestin Liver Dis. 2006 Jun;15(2):161-5.

  PMID: 16802011 BACKGROUND

• Dietrich CF, Jenssen C, Herth FJ. Endobronchial ultrasound elastography. Endosc Ultrasound. 2016 Jul-Aug;5(4):233-8. doi: 10.4103/2303-9027.187866.

  PMID: 27503154 BACKGROUND

• Dietrich CF, Saftoiu A, Jenssen C. Real time elastography endoscopic ultrasound (RTE-EUS), a comprehensive review. Eur J Radiol. 2014 Mar;83(3):405-14. doi: 10.1016/j.ejrad.2013.03.023. Epub 2013 May 1.

  PMID: 23643030 BACKGROUND

• Zhou BG, Wang D, Ren WW, Li XL, He YP, Liu BJ, Wang Q, Chen SG, Alizad A, Xu HX. Value of shear wave arrival time contour display in shear wave elastography for breast masses diagnosis. Sci Rep. 2017 Aug 1;7(1):7036. doi: 10.1038/s41598-017-07389-0.

  PMID: 28765627 BACKGROUND

• Zhang F, Zhao X, Han R, Du M, Li P, Ji X. Comparison of Acoustic Radiation Force Impulse Imaging and Strain Elastography in Differentiating Malignant From Benign Thyroid Nodules. J Ultrasound Med. 2017 Dec;36(12):2533-2543. doi: 10.1002/jum.14302. Epub 2017 Jun 24.

  PMID: 28646602 BACKGROUND

• Woo S, Suh CH, Kim SY, Cho JY, Kim SH. Shear-Wave Elastography for Detection of Prostate Cancer: A Systematic Review and Diagnostic Meta-Analysis. AJR Am J Roentgenol. 2017 Oct;209(4):806-814. doi: 10.2214/AJR.17.18056. Epub 2017 Aug 10.

  PMID: 28796546 BACKGROUND

• Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.

  PMID: 28055103 BACKGROUND

• Lim CK, Chung CL, Lin YT, Chang CH, Lai YC, Wang HC, Yu CJ. Transthoracic Ultrasound Elastography in Pulmonary Lesions and Diseases. Ultrasound Med Biol. 2017 Jan;43(1):145-152. doi: 10.1016/j.ultrasmedbio.2016.08.028. Epub 2016 Oct 12.

  PMID: 27743728 BACKGROUND

• Izumo T, Sasada S, Chavez C, Matsumoto Y, Tsuchida T. Endobronchial ultrasound elastography in the diagnosis of mediastinal and hilar lymph nodes. Jpn J Clin Oncol. 2014 Oct;44(10):956-62. doi: 10.1093/jjco/hyu105. Epub 2014 Aug 13.

  PMID: 25121724 BACKGROUND

• Furukawa MK, Kubota A, Hanamura H, Furukawa M. [Clinical application of real-time tissue elastography to head and neck cancer--evaluation of cervical lymph node metastasis with real-time tissue elastography]. Nihon Jibiinkoka Gakkai Kaiho. 2007 Jul;110(7):503-5. doi: 10.3950/jibiinkoka.110.503. Japanese.

  PMID: 17695297 BACKGROUND

• Rusch VW, Asamura H, Watanabe H, Giroux DJ, Rami-Porta R, Goldstraw P; Members of IASLC Staging Committee. The IASLC lung cancer staging project: a proposal for a new international lymph node map in the forthcoming seventh edition of the TNM classification for lung cancer. J Thorac Oncol. 2009 May;4(5):568-77. doi: 10.1097/JTO.0b013e3181a0d82e.

  PMID: 19357537 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Gu, master

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief physician, master

Model Details: Patients who underwent EBUS-TBNA examination in department of respiration,Nanjing Hospital Affiliated to Nanjing Medical University during 21June 2016 and 17 April 2017 were included in the study, All patients were evaluated by chest enhanced CT and/or 18-FDG PET-CT,those who had enlarged intrathoracic lymph nodes(≥1cm) and/or 18-FDG high uptake (SUV Max \> 2.5) without bleeding tendency, abnormal coagulation function and serious cardiac dysfunction.

Study Record Dates

• First Submitted: December 23, 2017
• First Posted: January 5, 2018
• Study Start: June 21, 2016
• Primary Completion: April 17, 2017
• Study Completion: December 31, 2018
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data is available now and in 3 years.
• Access Criteria: Researchers who are involved in the study of ultrasound elastography with lymph nodes and contact contact us via mail until our agreement.