Diagnosis and Classification of Pleural Diseases Using Ultrasound Channel Data

NCT04418804 | Unknown

• 1 other identifier: 0011-20-EMC
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumothorax; Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Ultrasound data

  Detection of pneumothorax or pleural effusion will be documented and assessed for the following parameters: Pneumothorax: 1. The presence of "lung sliding sign" in B bode. 2. The presence of "Comet tail artifacts" in B mode. 3. The "Barcode sign" mark in M mode. Pleural effusion: 1. Quantity of fluid according to acceptable clinical assessment: no fluid, minimal, medium, or large fluid. 2. Effusion characteristics by evaluation of Echogenicity, Homogenicity, presence of septations and loculations.

  1 year

Study Arms (3)

Healthy

EXPERIMENTAL

Participants without an active diagnosis of pleural disease.

Diagnostic Test: Chest ultrasound

Pneumothorax

EXPERIMENTAL

Participants diagnosed with pneumothorax during the past 24 hours.

Diagnostic Test: Chest ultrasound

Pleural effusion

EXPERIMENTAL

Participants diagnosed with current pleural effusion during the past 48 hours.

Diagnostic Test: Chest ultrasound

Interventions

Chest ultrasound DIAGNOSTIC_TEST

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.

Healthy; Pleural effusion; Pneumothorax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Israel Aharoni: lead
• Weizmann Institute of Science: collaborator

Study Sites (1)

Emek medical center

Afula, 1834111, Israel

RECRUITING

MeSH Terms

Conditions

Pneumothorax; Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Israel Israel, M.D. Ph.D

  Imaging institute, Haemek Medical Center, Afula, Israel.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Israel Aharony, M.D. Ph.D

CONTACT

97246495635; elik.aharony@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Radiology resident, HaEmek Medical Center Radiology institute, Principal investigator.

Model Details: Women and / or men over the age of 18 who expressed their consent to participate in the study and signed a formal consent form, will be divided into 3 groups according to their medical condition: 1. Participants without an active diagnosis of pleural disease. 2. Participants diagnosed with pneumothorax. 3. Participants diagnosed with pleural effusion.

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: December 1, 2020
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

IL (1)