- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05692141
The Value of Ultrasound Elastography for Differentiating Benign and Malignant Superficial Soft Tissue Masses
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The diagnostic imaging workup of soft tissue lesions begins with ultrasound and magnetic resonance imaging (MRI). In cases where the imaging features are not typical for a specific lesion (such as lipoma or ganglion cyst), imaging is insufficient to provide a definitive diagnosis, and these patients ultimately require a tissue sample by a percutaneous or excisional biopsy to guide further management.
In ultrasound, an emerging technology is an elastography which provides information on the stiffness of tissues. There are two main techniques, namely, strain elastography and shear wave elastography. In strain, or compression elastography, a force is applied to the tissues from the transducer by repetitive manual pressure, and the displacement (strain) is calculated from the return velocities of the tissues with respect to time. This creates a qualitative (color-coded) map of the elastic properties of the tissues. In shear wave elastography, vibration is applied to the tissues through a focussed ultrasound pulse, creating transverse shear waves in the tissues, the velocities of which can then be measured. Thus, shear wave elastography is a quantitative technique .
Patient selection This study will analyze patients who receive care at our institution patients with soft tissue masses. We retrospectively investigate patients' medical records, ultrasonographic exams, and histopathology reports Ultrasonographic Examination For each lesion, ultrasound Elastography would be performed using a Linear probe ; In Strain Elastography: Colors of the images represent different strain rates in decreasing order from red to green to blue. Based on the image colors, tissue elasticity was classified into 4 scores representing different stiffness: * score 1: completely red or green, * score 2: blue and green, with green as the dominant color, * score 3: blue and green, with blue as the dominant color, *score 4: completely blue. Strain rates of samples inside and outside the masses are measured to calculate the strain ratios (SRs).
In Shear Wave Elastography: The transducer is perpendicular to the lesion and stationary, without external compression. Grayscale images and color-coded histograms would be displayed with dual-mode imaging in real-time. In the chromatic scale, red indicates a higher shear modulus than blue. Several circular regions of interest (ROIs) with a diameter of 2 or 3 mm are placed within the lesion. The mean shear modulus for each ROI is measured automatically. We calculate the median value of several mean shear moduli corresponding to the ROIs, and this value is defined as the median shear modulus of the lesion. The unit of shear modulus values is the kilopascal (kPa)
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Aliaa Sayed, Resident
- Phone Number: 01094367328
- Email: hadeersayed2211@gmail.com
Study Contact Backup
- Name: Gehan Sayed, prof
- Phone Number: 01061622667
- Email: gehanseifeldein@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients with superficial masses
Exclusion Criteria:
- inflammatory lesions
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to investigate the value of ultrasound Elastography for differentiating benign and malignant superficial soft tissue masses .
Time Frame: baseline
|
to investigate the value of ultrasound Elastography for differentiating benign and malignant superficial soft tissue masses .
|
baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- elastography
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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