Shear-wave Elastography in Breast Cancer

NCT ID: NCT06123819

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2025-12-31

Brief Summary

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

Detailed Description

Breast cancer is the most common cancer of women world wide, and it is the second leading cause of death following lung cancer. Treatment options for breast cancer have changed in recent years; primary conventional surgery is no longer considered the most appropriate option for every patient.

The Age, molecular subtype, spread of the tumor, axillary lymph node status(as it is the first site to be metastasized by breast cancer through the lymphatic vessels) , and patient preference are the main determinants of breast cancer treatment, and a multidisciplinary approach is necessary.

With the development of molecular biology, it has been recognized that breast cancer has large biological diversity and high heterogeneity, which result in different morphological subtypes. According to immunehistochemical indexes such as estrogen receptor (ER), progesterone receptor (PR),proliferating cell nuclear antigen (Ki-67), and human epidermal growth factor receptor-2 (HER-2), clinicians determine 4 main molecular subtypes of breast cancer : -luminal A (ER+ or PR+, HER2-, andKi67 < 15%).

• luminal B (ER+ or PR+, HER2-/+,and Ki67 > 15%).
• triple negative (ER-, PR-, andHER2-).
• HER2+ (ER-, PR-, and HER2+). Determination of the molecular subtype of is the most important factor in systemic breast cancer treatment ; for example, it is generally preferred to use endocrine therapy in cases of hormone receptor positivity, anti-HER2 drugs in cases of human epidermal growth factor receptor2 (HER2) positivity, and chemotherapy in triple-negative patients.

The molecular subtype also determines recurrence and prognosis. For example, the triple negative subtype shows recurrence more frequently than other subtypes, while the luminal A subtype has a better prognosis.

Ultrasound (US) is an important modality for the detection and characterization of breast masses; it is also the first guiding method to be chosen for percutaneous biopsies in daily practice. Elastography is us based imaging modality recently developed to measure the elasticity of tissues using sound waves. Two-dimensional shear-wave elastography (SWE) is a newly emerging elastography technique, which can display tissue stiffness in a quantified form to obtain the biological information of the primary lesion . At present, many studies have verified the diagnostic value of SWE for benign and malignant lesions in breasts . The technique has been widely employed to check the thyroid, pancreas, kidney, prostate, liver, and other organs while few studies about axillary node metastasis (ANM) and its application for the molecular classification of breast cancer were reported .

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

elastography

. 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 .

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Walaa Gamal Abdelnasser

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sherin ezzat

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Walaa G Abdelnasser

Role: CONTACT

walaa.wg97@gmail.com

01061683194

Doaa M fouad

Role: CONTACT

doaafouad11@gmail.com

01027294427

References

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.

Reference Type: BACKGROUND

PMID: 23988689 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24041435 (View on PubMed)

Other Identifiers

shear-wave in breast cancer

Identifier Type: -

Identifier Source: org_study_id