Monitoring the Response of Breast Cancer to Neoadjuvant Chemotherapy Using SE and SWENCT05852743
Comparative Study Between Shear and Strain Elastography in Monitoring the Response to NAC in Breast Cancer Patients
An observational study of Monitoring the Response of Breast Cancer to Neoadjuvant Chemotherapy Using SE and SWE, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Monitoring the Response of Breast Cancer to Neoadjuvant Chemotherapy Using SE and SWE
- What is being tested?
- shear wave and strain elastography
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Adult, Older adult
Study population: a total of 65 female patient with biopsy confirmation of invasive breast cancer
Who may be able to join
- Histologically confirmed invasive ductal carcinoma .
- Age equal or above 18
Who cannot join
- Previous radiation therapy or chemotherapy
- Mass not detected by US
- Non Mass lesion by MRI
- Ductal carcinoma in situ
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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)
- Being tested
- shear wave and strain elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shear wave and strain elastographyDevice
shear wave elastography is a quantitative technique , while strain elastography is qualitative technique
What is being measured
The primary outcome is the main question the study is designed to answer.
comparative study between shear and strain elastography in monitoring the response of breast cancer to neoadjuvant chemotherapy
evaluate tumor stiffness changes through a comparative study between shear and strain elastography in monitoring the response of breast cancer to neoadjuvant chemotherapy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study startAug 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monitoring the Response of Breast Cancer to Neoadjuvant Chemotherapy Using SE and SWEStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Gamal Rasmy, Assiut University
- Investigators
- Lamiaa Mohamed Refaat, Study chair, Ass.Professor docotor ,diagnostic radiology department , in south egypt cancer instituteShereen Ezzat Amin, Study chair, lecturer doctor , diagnostic radiology department , in south egypt cancer instituteEman Abo Elhamd, Study chair, Professor doctor , diagnostic radiology department , assuit university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852743
- Sponsor's protocol ID
- SE and SWE in BC patients
- Status last verified
- May 2023
- First submitted
- 1 May 2023
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Shear and Strain Elastography in Monitoring the Response to NAC in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05852743
- Acronym / sponsor ID
- SE and SWE in BC patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- a total of 65 female patient with biopsy confirmation of invasive breast cancer
Key inclusion criteria (2 listed)
- Histologically confirmed invasive ductal carcinoma .
- Age equal or above 18
Key exclusion criteria (4 listed)
- Previous radiation therapy or chemotherapy
- Mass not detected by US
- Non Mass lesion by MRI
- Ductal carcinoma in situ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shear wave and strain elastographyshear wave elastography is a quantitative technique , while strain elastography is qualitative technique | Device | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lamiaa Mohamed Refaat study chair
Ass.Professor docotor ,diagnostic radiology department , in south egypt cancer institute
Shereen Ezzat Amin study chair
lecturer doctor , diagnostic radiology department , in south egypt cancer institute
Eman Abo Elhamd study chair
Professor doctor , diagnostic radiology department , assuit university
Questions about this trial
What is this clinical trial studying?
An observational study of Monitoring the Response of Breast Cancer to Neoadjuvant Chemotherapy Using SE and SWE, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Gamal Rasmy (01289374337, dsilviajesus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparative study between shear and strain elastography in monitoring the response of breast cancer to neoadjuvant chemotherapy (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.