Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04418804
Other study ID # 0011-20-EMC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date December 2024

Study information

Verified date September 2023
Source HaEmek Medical Center, Israel
Contact Israel Aharony, M.D. Ph.D
Phone 97246495635
Email elik.aharony@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: The Pleura is a double-layered membrane that surrounds the lungs. Pathological processes that involve the Pleura are called "Pleural diseases". Among them are included Pneumothorax (Air the chest cavity), Pleural effusions, and tumor formation. Ultrasound imaging of the Pleura to detect and assess pleural diseases has been proven as an excellent diagnostic and safe option. Ultrasound test uses sound waves to characterize the structure and function of different organs in health and disease. The standard technique used to create two-dimensional ultrasound picture is called Delay and Sum (DAS). Signals are transmitted and received from a series of elements and allow a two dimensional picture to be created. Because a large number of sensors is required, creating a two dimensional picture creates a large and usually redundant data pool. This fact leads to a need for stronger processors and larger operating systems, Consumption of higher energy, and hence an ungainly, slow, and expensive system. Signal Acquisition Modeling and Processing Laboratory (SAMPLE) in Weizmann institute has developed a data processing system that allows narrowing down the number of elements needed to process the ultrasound signal, while creating an ultrasound picture of abdominal organs in a satisfying resolution. Sometimes even better than standard methods. Research goal: Improvement of diagnosis and characterization of pleural diseases by Ultrasound, using a novel algorithm that was developed in SAMPLE laboratory in Weizmann Institute. The aim is to create a faster, more reliable ultrasound imaging while minimizing sampling rate and data volume. Methods: Tested population: Women and/or men who were diagnosed with Pneumothorax or Plural effusion with other imaging modalities, and healthy volunteers as a control group, Up to 30 participants per each group (Total up to 90), in a 1:1:1 Ratio. Research type: An open-labeled study. Experimental design: Participants that will meet the required conditions will be summoned to an exam in our imaging institute or will be scanned bedside, using the Verasonics ultrasound system, which allows free access to ultrasound raw Channel data. The information acquired, as well as other imaging scans of the participant, will be coded and delivered anonymously to SAMPLE laboratory for analysis.


Description:

Background and rationale: The Pleura is a double-layered membrane surrounding the lungs. It is anatomically divided into Visceral Pleura, which is attached to the outer part of the lungs, and to the Parietal Pleura, which is attached to the inner side of the rib cage. Pathological processes involving the Pleura are incorporated under the name "Pleural diseases" which include, among others, pneumothorax, pleural effusion, and various tumors. This disease group is relatively widespread, and as evidence that the incidence reported in the literature is over 300 to 100,000 people in one year. Diagnosis and evaluation of pleural disease involve the use of various neuroimaging devices such as chest radiographs, ultrasound, CT, and MRI. Most often, chest radiographs are widely accepted as the first means of identifying pleural diseases, with ultrasound, CT, and MRI supplementing or constituting a diagnostic confirmation if necessary. Over the past few years, a significant perceptual change has been made in the use of chest ultrasound to diagnose pleural diseases as part of emergent and none emergent situations. Ultrasound has been shown to be an excellent imaging device for the assessment of pleural diseases. It is used as an auxiliary in a variety of clinical situations, such as pneumothorax detection in emergency situations, characterization of pleural fluid as simple or complex, the distinction between pleura thickening and pleural fluid loculations, and more. In addition to the diagnostic aspect, the ultrasound serves as a means of performing invasive operations in the chest. The use of ultrasound imaging for the chest is increasing, resulting in a significant increase in the quality of the diagnosis and a decrease in the incidence of various complications. The ultrasound test uses sound waves to characterize various organ structure and function in health and disease. The test does not involve the use of ionizing radiation, so its use is safer than other techniques such as chest x-rays or CT examinations. The acquired and viewed images in the ultrasound device are real-time, so that changes can be detected and evaluated, which in many cases affects the final diagnosis. The test is non-invasive and does not require the use of contrast material containing substances that may cause an allergic reaction or impairment of kidney function. In addition, the instrumentation is more readily available for use at bedside examinations, and most tests do not require special preparations except for up to 6 hours of fasting in some cases. On the other side, ultrasound testing has its drawbacks as well. The method is highly dependent on the operator's skill, so a great deal of experience is required to produce sufficient quality information and to make an accurate diagnosis. The ultrasound does not penetrate well through bones, and the quality of the test is impaired by the presence of air between the transducer and the organ or area being examined. In addition, the quality of the test is highly dependent on the subject's cooperation during the test, such as posture changes and deep breathing. The standard technique for creating a standard 2D ultrasound image is now called Delay and Sum (DAS). Signals are transmitted and received from a series of elements, and by appropriate spacing of each signal, the signal readout can be focused in the required direction and distance. Due to the need for many sensors, a significant amount of data is required to produce the desired 2D picture. This fact leads to a need of using stronger processors, resulting in higher energy consumption, larger and more expensive operating systems. Therefore, Lowering the number of required samples while effectively processing the signals allows creating a high-quality 2D image, while narrowing down the burden of unnecessary data. The SAMPL Laboratory at the Weizmann Institute demonstrated this data processing method with ultrasound tests on stationary organs such as the liver and kidneys where the number of elements needed for signal processing could be reduced for the purpose of creating an ultrasound image with a smaller volume of information, while not compromising on picture quality. Objectives of the medical experiment: The purpose of this study is to improve the diagnosis and characterization of pleural diseases by ultrasound, using a new algorithm developed in the SAMPL laboratory at the Weizmann Institute. The goal is to enable a fast and reliable diagnostic tool comparable to the ultrasound imaging used today while minimizing the sampling rate and volume of information. Technical details: B-Mode, M-Mode, and Doppler operation of an Ultrasonic system can provide spatial-, temporal- and motion-related aspects of Pleural composition and dynamics. The standard technique used by commercial medical ultrasound systems for B-mode imaging is delay and sum (DAS) beamforming. However, DAS often yields images of limited resolution and contrast, which are governed by the center frequency and the aperture size of the ultrasound transducer. A large number of elements leads to improved resolution, but simultaneously increases data size and system cost due to receiver electronics required per element. The reduction of receiving channels while producing high-quality images is thus of great importance. Methods and algorithms developed at SAMPL, such as the Convolutional Beamforming Algorithm (COBA), can be used to achieve significant improvement of lateral resolution and contrast. COBA can also be implemented efficiently using the fast Fourier transform. Based on this concept, sparse beamformers were developed, resulting in the same beam pattern as DAS and COBA while using far fewer array elements. Optimization of the number of elements shows an approximate square-root reduction in required elements, compared to DAS. The performance of the proposed methods was tested and validated using simulated data, phantom scans and in vivo cardiac data. The technique may be applied to Pleural disease detection, allowing for both improved image quality and reduction of the number of elements used to produce an image, and therefore ultimately facilitate cheap, portable, and wireless ultrasound imaging. In addition, the methods developed at SAMPL yield imaging that is fully dedicated to the assessment of pleural pathologies, enabling straightforward interpretation even by untrained clinicians. Jointly, wireless, cheap, and portable lung imaging, along with straightforward interpretation opens up a wealth of opportunities, spanning from fast diagnosis of pneumothorax in ambulatory (trauma) settings as well as in rural clinics and developing countries. Equipment: The Verasonics Vantage ultrasound system is an ultrasound system suitable for human research use. This system allows for raw sound wave data to be retrieved when performing ultrasound scanning. Data security: Volunteers will be scanned at Haemek Medical Center (As detailed in the "Intervention" section), and the data will be processed at the SAMPL laboratory at the Weizmann Institute. All information transmitted to the laboratory at the Weizmann Institute will be encoded beforehand, i.e. removing identifying information such as name, identification number, address, and assignment of a serial number by the medical center, so that the patient information is will be unavailable to SAMPL laboratory. Transferring the images from the imaging tests will be done after encoding the tested information in an Excel file. Only the primary investigator will be exposed to pre-coding information, which will be stored on a dedicated computer by the primary investigator, password protected. The encoded information will be transmitted continuously to the Weizmann Institute, in order to ensure reliable data acquisition and the possibility of real-time feedback to the principal investigator in favor of higher quality data enabling data analysis.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Healthy volunteers - Volunteers with active Pneumothorax, detected by prior imaging studies up to 24 hours before the ultrasound scan - Volunteers with active Pleural effusion, detected by prior imaging studies up to 48 hours before the ultrasound scan ult Exclusion Criteria: - Volunteers with the aforementioned diagnosis, which was not detected during the actual ultrasound exam - Volunteers who expressed their desire to be excluded from the study at any given time point.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Chest ultrasound
Each research volunteer will undergo a chest-directed ultrasound examination using a commercial device located in the Valley Hospital and approved for clinical use. After completing the above scan, the patient will undergo another ultrasound scan using a Vantage system device (by Verasonics), which is a research ultrasound device that will be provided on loan to the Haemek Hospital by the Weizmann Institute SAMPL Laboratory prior to the start of the trial. The scan will be made with a linear transducer sampled at a rate of about 8-12Mhz and / or with a curved transducer sampled at a rate of about 4-6Mhz. The total estimated duration of the test is approximately 30 to 40 minutes per patient.

Locations

Country Name City State
Israel Emek medical center Afula

Sponsors (2)

Lead Sponsor Collaborator
Israel Aharoni Weizmann Institute of Science

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ultrasound data Detection of pneumothorax or pleural effusion will be documented and assessed for the following parameters:
Pneumothorax:
The presence of "lung sliding sign" in B bode.
The presence of "Comet tail artifacts" in B mode.
The "Barcode sign" mark in M mode.
Pleural effusion:
Quantity of fluid according to acceptable clinical assessment: no fluid, minimal, medium, or large fluid.
Effusion characteristics by evaluation of Echogenicity, Homogenicity, presence of septations and loculations.
1 year
See also
  Status Clinical Trial Phase
Completed NCT04159831 - A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions Phase 2
Recruiting NCT02891642 - Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
Completed NCT02232841 - Electrical Impedance Imaging of Patients on Mechanical Ventilation N/A
Completed NCT02045641 - Pleural and Pericardial Effusion Following Open Heart Surgery N/A
Completed NCT01948076 - Evaluation of a Pocket-Sized Ultrasound Device As an Aid to the Physical Examination N/A
Completed NCT01416519 - Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation N/A
Completed NCT01560078 - Efficacy Study of Thrice Weekly Directly Observed Treatment Short-Course Regimen in Tubercular Pleural Effusion N/A
Completed NCT04891705 - Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study
Recruiting NCT05759117 - Prospective Evaluation of Patients With Pleural Effusion
Recruiting NCT05910112 - Prospective Data Collection on Clinical, Radiological and Patient Reported Outcomes After Pleural Intervention
Completed NCT03896672 - Clinical Implementation of the Use of Positive Pressure in Chest Drainage N/A
Active, not recruiting NCT06075836 - AI Assisted Detection of Chest X-Rays
Recruiting NCT03728491 - Education and Training Competences in Thoracic Ultrasound N/A
Completed NCT03535883 - The Safety of Thoracentesis, Tunneled Pleural Catheter, and Chest Tubes in Patients Taking Novel Oral Anti-Coagulants
Not yet recruiting NCT03260088 - Evaluation Of Pleural Effusion At Assiut University Hospital N/A
Completed NCT03296280 - Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program
Completed NCT03661801 - Novel Pleural Fluid, Biopsy and Serum Biomarkers for the Investigation of Pleural Effusions
Completed NCT01778270 - Not Invasive Monitoring of Pleural Drainage N/A
Terminated NCT00402896 - Malignant Pleural Effusion With ZD6474 Phase 2
Recruiting NCT00103766 - Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion N/A