Diagnostic Value of Strain Elastography in Characterization of Solid Breast Lesions.

NCT07649590 | Completed

• 1 other identifier: Sog-Med--24-12-08MS
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Breast Lesions

Outcome Measures

Primary Outcomes (1)

• Assessment of the mass harness by elastography

  assessmnet of the mass harness by elasography ration E2/E1

  one year

Interventions

Ultrasound RADIATION

examination by Ultrasound

Eligibility Criteria

• Age: 20 Years - 50 Years
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Woman aged 18 years or older. * Having solid breast lesions identified through mammography or ultrasound and who are scheuduled for biopsy

You may qualify if:

• Woman aged 18 years or older.
• Having solid breast lesions identified through mammography or ultrasound and who are scheuduled for biopsy

You may not qualify if:

• Patient with proor breast surgeries
• patient who had alocalzied systemic diseases that prevents biopsy.
• Inflammtory conditions

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

Location

Related Publications (3)

• 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.

  PMID: 32330993 BACKGROUND

• 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.

  PMID: 38149832 BACKGROUND

• 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.

  PMID: 35151365 BACKGROUND

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at diagnostic and interventional radiology department

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: June 16, 2026
• Study Start: January 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

EG (1)