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

May 1, 2023 updated by: Silvia Gamal Rasmy, Assiut University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

a total of 65 female patient with biopsy confirmation of invasive breast cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparative study between shear and strain elastography in monitoring the response of breast cancer to neoadjuvant chemotherapy
Time Frame: baseline
evaluate tumor stiffness changes through a comparative study between shear and strain elastography in monitoring the response of breast cancer to neoadjuvant chemotherapy
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2023

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

May 1, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE and SWE in BC patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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