E- Predict: EBUS ELASTOGRAPHY STRAIN in Lung Cancer

Lung Cancer Clinical Trial

— E-PREDICT  

Official title:

E-PREDICT Evaluating the Predictive Value of EBUS ELASTOGRAPHY STRAIN in Patients With (Suspected) Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488928
• Other study ID #: 2015-1676
• Status: Completed
• Start date: July 2015
• Est. completion date: April 2019

Study information

• Verified date: May 2018
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

EBUS elastography is a method to determine stiffness of lymph nodes, based on the minute deformation of the node by the beating heart. Whether EBUS elastography may further increase the sensitivity to predict the presence or absence of malignancy is unclear.

We suggest to use EBUS elastography strain pattern analysis for this assessment and correlate these measurements with the final pathology outcome to determine NPV, PPV, sensitivity and specificity of this analysis to predict the presence or absence of malignancy in patients with (suspected) lung cancer in a prospectively obtained observational cohort study.

Description:

Patients will undergo a routine EBUS and/or EUS or EUSb with Pentax series EBUS or EUS scopes in combination with Hitachi Preirus Hi-Vision ultrasound processor with installed elastography software. Normal international guidelines for staging, diagnosis and specimen acquisition will be followed. For a normal evaluation B-mode measurements from all lymph node regions are obtained assessing size and standard ultrasound characteristics and all lymph nodes in the regions of interest that meet the criteria for fine needle aspiration will be sampled. For this study, in addition to the normal B-mode assessment of five sonographic B-mode characteristics elastography strain graph video, elastography image, and a strain histogram from the region of interest will be obtained.

Fine needle aspiration for cytology evaluation will be obtained from nodes based on imaging characteristics or standard sonography characteristics following current everyday clinical practice and the international guidelines. Subsequently, the patient charts will be retrospectively analysed after completion of the diagnostic and/or surgical treatment of the (suspected) lung cancer to match the obtained imaging data to pathology results (cytology and or histology where present) and clinical follow up until 6 months after the diagnostic procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: April 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with indication for diagnostic or staging EBUS procedure for suspected or proven lung cancer.

• ASA physical status 1-3.

• Age 18 years or older.

Exclusion Criteria:

• Bleeding disorders.

• Contra-indication for temporary interruption of the use of anticoagulant therapy (acenocoumarol, warfarin, therapeutic dose of low molecular weight heparines or clopidrogel).

• Known allergy for lidocaine.

• Uncontrolled pulmonary hypertension.

• Recent and/or uncontrolled cardiac disease.

• Compromised upper airway (eg concomitant head and neck cancer or central airway stenosis for any reason).

• Prior radiotherapy treatment involving the central airways

• ASA classification greater than or equal to 4.

• Pregnancy.

• Inability to consent.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Italy	Interventional Pulmonology Unit Policlinico S. Orsola-Malpighi	Bologna
Italy	Azienda Ospedaliera Universitaria di Careggi	Firenze
Italy	Ausl Modena - Ospedale Santa Maria Bianca	Modena
Italy	Pesaro-Fano Hospital	Pesaro
Netherlands	Academic Medical Center	Amsterdam
Netherlands	RadboudUMC	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Countries where clinical trial is conducted

Denmark,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stiffness of lymph nodes	stiffness/strain is a relative measure and has therefor no units	participants will be followed for the duration of hospital stay, an expected average of 4 hours