E-PREDICT: E- Predict: EBUS ELASTOGRAPHY STRAIN in Lung Cancer

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02488928

Collaborator

(none)

327

Enrollment

Locations

Actual Duration (Months)

46.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

327 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Apr 1, 2019

Outcome Measures

Primary Outcome Measures

stiffness of lymph nodes [participants will be followed for the duration of hospital stay, an expected average of 4 hours]
stiffness/strain is a relative measure and has therefor no units

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark	Dk 2100
2	Interventional Pulmonology Unit Policlinico S. Orsola-Malpighi	Bologna		Italy	40138
3	Azienda Ospedaliera Universitaria di Careggi	Firenze		Italy	50100
4	Ausl Modena - Ospedale Santa Maria Bianca	Modena		Italy	41037
5	Pesaro-Fano Hospital	Pesaro		Italy
6	RadboudUMC	Nijmegen	Gelderland	Netherlands	6500 HB
7	Academic Medical Center	Amsterdam		Netherlands	1105 AZ