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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05852743
Collaborator
(none)
65
32

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: shear wave and strain elastography

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)

Study Design

Study Type:
Observational
Anticipated Enrollment :
65 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparative Study Between Shear and Strain Elastography in Monitoring the Response to NAC in Breast Cancer Patients
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Apr 1, 2026

Outcome Measures

Primary Outcome Measures

  1. comparative study between shear and strain elastography in monitoring the response of breast cancer to neoadjuvant chemotherapy [baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Lamiaa Mohamed Refaat, Ass.Professor docotor ,diagnostic radiology department , in south egypt cancer institute
  • Study Chair: Shereen Ezzat Amin, lecturer doctor , diagnostic radiology department , in south egypt cancer institute
  • Study Chair: Eman Abo Elhamd, Professor doctor , diagnostic radiology department , assuit university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Silvia Gamal Rasmy, Resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05852743
Other Study ID Numbers:
  • SE and SWE in BC patients
First Posted:
May 10, 2023
Last Update Posted:
May 10, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2023