- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05852743
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
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
- Name: Silvia Gamal Rasmy
- Phone Number: 01289374337
- Email: dsilviajesus@gmail.com
Study Contact Backup
- Name: Lamiaa Mohamed Refaat
- Phone Number: 01003386186
- Email: lamiaa_refaat@yahoo.com
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:
- Histologically confirmed invasive ductal carcinoma .
- Age equal or above 18
Exclusion Criteria:
- Previous radiation therapy or chemotherapy
- Mass not detected by US
- Non Mass lesion by MRI
- 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
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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