Diagnosis and Classification of Pleural Diseases Using Ultrasound Channel Data

NCT04418804 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-09-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Weizmann Institute of Science

    collaborator OTHER
  • Israel Aharoni

    lead OTHER

Principal Investigators

  • Israel Israel, M.D. Ph.D · Imaging institute, Haemek Medical Center, Afula, Israel.

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2024-08-31
Completion
2024-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04418804 on ClinicalTrials.gov