- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07649590
Diagnostic Value of Strain Elastography in Characterization of Solid Breast Lesions.
Breast lesions are a common concern in clinical practice, requiring accurate diagnostic tools for effective evaluation. Traditional imaging modalities, such as mammography and ultrasound, play critical roles in detecting and characterizing these lesions. However, the emergence of advanced techniques like strain elastography has significantly enhanced our ability to assess the mechanical properties of breast tissues, providing valuable insights beyond standard imaging. Strain elastography is a non-invasive ultrasound-based technique that evaluates tissue stiffness by measuring the degree of deformation in response to applied pressure. This technique capitalizes on the principle that malignant tissues are typically stiffer than benign ones, offering a potential method for differentiating between solid breast lesions. By assessing the elastic properties of breast tissues, strain elastography aids in improving diagnostic accuracy and reducing the need for unnecessary biopsies.
The diagnostic value of strain elastography lies in its ability to provide real-time feedback during ultrasound examinations. This immediacy allows clinicians to make informed decisions about further management based on the mechanical characteristics of the lesions. The integration of strain elastography into routine breast imaging protocols can enhance the specificity and sensitivity of lesion characterization, ultimately benefiting patient outcomes.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Sohag, Egypt
- Sohag University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Woman aged 18 years or older.
- Having solid breast lesions identified through mammography or ultrasound and who are scheuduled for biopsy
Description
Inclusion Criteria:
- Woman aged 18 years or older.
- Having solid breast lesions identified through mammography or ultrasound and who are scheuduled for biopsy
Exclusion Criteria:
- Patient with proor breast surgeries
- patient who had alocalzied systemic diseases that prevents biopsy.
- Inflammtory conditions
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of the mass harness by elastography
Time Frame: one year
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assessmnet of the mass harness by elasography ration E2/E1
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one year
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Cantisani V, David E, Barr RG, Radzina M, de Soccio V, Elia D, De Felice C, Pediconi F, Gigli S, Occhiato R, Messineo D, Fresilli D, Ballesio L, D'Ambrosio F. US-Elastography for Breast Lesion Characterization: Prospective Comparison of US BIRADS, Strain Elastography and Shear wave Elastography. Ultraschall Med. 2021 Oct;42(5):533-540. doi: 10.1055/a-1134-4937. Epub 2020 Apr 24.
- Li X, Sun W, Zhang H. The value of elastography strain rate ratio in benign and malignant BI-RADS-US 3-4 breast masses. Biomol Biomed. 2024 May 2;24(3):625-632. doi: 10.17305/bb.2023.9878.
- Mutala TM, Mwango GN, Aywak A, Cioni D, Neri E. Determining the elastography strain ratio cut off value for differentiating benign from malignant breast lesions: systematic review and meta-analysis. Cancer Imaging. 2022 Feb 12;22(1):12. doi: 10.1186/s40644-022-00447-5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sog-Med--24-12-08MS
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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