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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Silvia Gamal Rasmy contact

01289374337

dsilviajesus@gmail.com

Lamiaa Mohamed Refaat contact

01003386186

lamiaa_refaat@yahoo.com

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.

  1. 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.

  1. First posted10 May 2023
  2. Study startAug 2023 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

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)
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

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.

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