Clinical trial NCT05852743: Comparative Study Between Shear and Strain Elastography in Monitoring the Response to NAC in Breast Cancer Patients
Official title: Comparative Study Between Shear and Strain Elastography in Monitoring the Response to NAC in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Monitoring the Response of Breast Cancer to Neoadjuvant Chemotherapy Using SE and SWE
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a total of 65 female patient with biopsy confirmation of invasive breast cancer

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)

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

Primary outcomes:
measure: comparative study between shear and strain elastography in monitoring the response of breast cancer to neoadjuvant chemotherapy
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ass.Professor docotor ,diagnostic radiology department , in south egypt cancer institute
name: Lamiaa Mohamed Refaat
role: STUDY_CHAIR
affiliation: lecturer doctor , diagnostic radiology department , in south egypt cancer institute
name: Shereen Ezzat Amin
role: STUDY_CHAIR
affiliation: Professor doctor , diagnostic radiology department , assuit university
name: Eman Abo Elhamd
role: STUDY_CHAIR
References: