Comparative Study Between Shear and Strain Elastography in Monitoring the Response to NAC in Breast Cancer Patients

NCT ID: NCT05852743

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2026-04-30

Brief Summary

The aim is to evaluate tumor stiffness changes through a comparative study between shear and strain elastography in monitoring the response of breast cancer to neoadjuvant chemotherapy

Detailed Description

Breast cancer (BC) is one of the most common malignant tumors in global population, with the highest morbidity and mortality rates among female.(1) Neoadjuvant chemotherapy (NAC) has become an important supplement of comprehensive and precise treatment of BC. Neoadjuvant chemotherapy (NAC) is increasingly used to induce tumor shrinkage, thereby allowing smaller surgical resection, eliminating clinically silent micro metastases, and providing prognostic information based on the extent of pathologic response(.2-4) Pathological complete response (pCR) is increasingly seen after neoadjuvant chemotherapy (NACT) for invasive breast cancer. Confident identification of pCR may lead to less radical breast surgery and to sentinel node biopsy rather than axillary clearance in women with pre-treatment positive nodes.(5)Response to NACT is routinely assessed using magnetic resonance imaging (MRI), greyscale ultrasound (US), and mammography.(6) In some studies, MRI has been shown to be superior to US.(7-8) however, MRI has the disadvantages of being time-consuming, expensive, requiring intravenous contrast agent . Ultrasonic elastography (UE) has been widely used to qualitatively and quantitatively evaluate differences in lesion stiffness or elasticity. Currently, the two most frequently used UE techniques for examination of breast diseases are strain elastography (SE) and shear-wave elastography (SWE). In practice, UE is a complementary technique for differentiating benign from malignant breast masses (9,10). Breast cancers with more aggressive pathological properties tend to have higher stiffness values .Strain elastography (SE) may be predictive of response in the early stage of treatment with high sensitivity (SEN) and specificity (SPE).(11,12) Pretreatment tumor stiffness measured by shear wave elastography (SWE) has a significant relationship with the subsequent reduction in tumor cellularity.(13) In case of NACT, early evaluation of relative changes in tumor stiffness could effectively predict the response and might indicate better therapeutic strategies.(14)

Conditions

Monitoring the Response of Breast Cancer to Neoadjuvant Chemotherapy Using SE and SWE

Study Design

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

Interventions

shear wave and strain elastography

shear wave elastography is a quantitative technique , while strain elastography is qualitative technique

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed invasive ductal carcinoma .

2. Age equal or above 18

Exclusion Criteria

1. Previous radiation therapy or chemotherapy

2. Mass not detected by US

3. Non Mass lesion by MRI

4. Ductal carcinoma in situ

• 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

Silvia Gamal Rasmy

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lamiaa Mohamed Refaat

Role: STUDY_CHAIR

Ass.Professor docotor ,diagnostic radiology department , in south egypt cancer institute

Shereen Ezzat Amin

Role: STUDY_CHAIR

lecturer doctor , diagnostic radiology department , in south egypt cancer institute

Eman Abo Elhamd

Role: STUDY_CHAIR

Professor doctor , diagnostic radiology department , assuit university

Central Contacts

Silvia Gamal Rasmy

Role: CONTACT

dsilviajesus@gmail.com

01289374337

Lamiaa Mohamed Refaat

Role: CONTACT

lamiaa_refaat@yahoo.com

01003386186

Other Identifiers

SE and SWE in BC patients

Identifier Type: -

Identifier Source: org_study_id