Shear-wave Elastography in Breast Cancer

NCT06123819 | Unknown

• 1 other identifier: shear-wave in breast cancer
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the relationship of the SWE elastic modulus and the molecular types of breast cancer .

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Changes in the tumor stiffness values on SWE were significantly associated with aggressive histopathologic features of breast cancer.

  We analyze 545 consecutive women (mean age, 52.7 ± 10.7 years; range, 26-83) with breast cancer who underwent preoperative breast ultrasound with SWE parameters (Emax, Emean, and Eratio) and the histopathologic information from surgical specimens including histologic type, histologic grade, size of invasive cancer, hormone receptor and HER2 status, Ki-67 proliferation index, and axillary LN status were analyzed. The relationships between SWE parameters and histopathologic findings were analyzed using an independent sample t-test, one-way ANOVA test with Tukey's post hoc test, andlogistic regression analyses.

  baseline

Interventions

elastography DEVICE

. First, strain elastography (it is based upon the fact that hard tissue is more difficulty compressed than soft tissue. SE is a technique that measures the tissue deformation generated by compression, which may be applied with a probe on the body surface for static imaging) will be performed. The elastogram image of the detected lesion, will be evaluated Using color coding ranging from blue, through green and red. All lesions will be scored on elastogram in terms of their Stiffness compared to normal parenchyma. Second, shear wave elastography (is a method to generate shear waves and measure SWV ,based on the principle of fast propagation of shear wave speed in hard tissue and slow propagation in soft tissue , the hardness of tissue is indirectly reflected by measuring shear wave speed ) , will also be calculated individually.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Based on determining the main outcome variable ,the estimated minimum required sample size is 60 patients. The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is correlate various pattern of non mass lesions with histopathology for further management. Based on previos accuracy is 81%. Based on this percentage confidence limits of 6% and a confidence level=80%.

You may qualify if:

• Women who were diagnosed with invasive breast cancer and did not receive neoadjuvant treatment and who previously did not have an operation on the same breast or axillary fossa .

You may not qualify if:

• Women who were diagnosed with non-invasive breast cancer and who receive neoadjuvant treatment and who previously had an operation on the same breast or axillary fossa .
• patients who expressed their oppositionto the use of their personal data.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Gweon HM, Youk JH, Son EJ, Kim JA. Clinical application of qualitative assessment for breast masses in shear-wave elastography. Eur J Radiol. 2013 Nov;82(11):e680-5. doi: 10.1016/j.ejrad.2013.08.004. Epub 2013 Aug 14.

  PMID: 23988689 BACKGROUND

• Yoon JH, Ko KH, Jung HK, Lee JT. Qualitative pattern classification of shear wave elastography for breast masses: how it correlates to quantitative measurements. Eur J Radiol. 2013 Dec;82(12):2199-204. doi: 10.1016/j.ejrad.2013.08.047. Epub 2013 Sep 3.

  PMID: 24041435 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• sherin ezzat

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Walaa G Abdelnasser

CONTACT

01061683194; walaa.wg97@gmail.com

Doaa M fouad

CONTACT

01027294427; doaafouad11@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 9, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 9, 2023

Record last verified: 2023-11