Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852743
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-10
First Post:
2023-05-01
Brief Title:
Comparative Study Between Shear and Strain Elastography in Monitoring the Response to NAC in Breast Cancer Patients
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Comparative Study Between Shear and Strain Elastography in Monitoring the Response to NAC in Breast Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 female1 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 response2-4 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 nodes5Response to NACT is routinely assessed using magnetic resonance imaging MRI greyscale ultrasound US and mammography6 In some studies MRI has been shown to be superior to US7-8 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 910 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 SPE1112 Pretreatment tumor stiffness measured by shear wave elastography SWE has a significant relationship with the subsequent reduction in tumor cellularity13 In case of NACT early evaluation of relative changes in tumor stiffness could effectively predict the response and might indicate better therapeutic strategies14
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None