Solid Breast LesionsNCT07649590
Diagnostic Value of Strain Elastography in Characterization of Solid Breast Lesions.
An observational study of Solid Breast Lesions, run by Sohag University at 1 site in Egypt.
Trial summary
Breast lesions are a common concern in clinical practice, requiring accurate diagnostic tools for effective evaluation. Traditional imaging modalities, such as mammography and ultrasound, play critical roles in detecting and characterizing these lesions. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Solid Breast Lesions
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jun 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 20 to 50 years
- Women only
- Adult
Study population: Woman aged 18 years or older. * Having solid breast lesions identified through mammography or ultrasound and who are scheuduled for biopsy
Who may be able to join
- Woman aged 18 years or older.
- Having solid breast lesions identified through mammography or ultrasound and who are scheuduled for biopsy
Who cannot join
- Patient with proor breast surgeries
- patient who had alocalzied systemic diseases that prevents biopsy.
- Inflammtory conditions
Trial locations and contacts
1 site in 1 country.
About this study
Breast lesions are a common concern in clinical practice, requiring accurate diagnostic tools for effective evaluation. Traditional imaging modalities, such as mammography and ultrasound, play critical roles in detecting and characterizing these lesions. However, the emergence of advanced techniques like strain elastography has significantly enhanced our ability to assess the mechanical properties of breast tissues, providing valuable insights beyond standard imaging. Strain elastography is a non-invasive ultrasound-based technique that evaluates tissue stiffness by measuring the degree of deformation in response to applied pressure. This technique capitalizes on the principle that malignant tissues are typically stiffer than benign ones, offering a potential method for differentiating between solid breast lesions. By assessing the elastic properties of breast tissues, strain elastography aids in improving diagnostic accuracy and reducing the need for unnecessary biopsies.
The diagnostic value of strain elastography lies in its ability to provide real-time feedback during ultrasound examinations. This immediacy allows clinicians to make informed decisions about further management based on the mechanical characteristics of the lesions. The integration of strain elastography into routine breast imaging protocols can enhance the specificity and sensitivity of lesion characterization, ultimately benefiting patient outcomes.
- Conditions
- Solid Breast Lesions
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundRadiation
examination by Ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the mass harness by elastography
assessmnet of the mass harness by elasography ration E2/E1
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Jan 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Solid Breast LesionsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Yahia Abdellah, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649590
- Sponsor's protocol ID
- Sog-Med--24-12-08MS
- Status last verified
- Jun 2026
- First submitted
- 29 Dec 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cantisani V, David E, Barr RG, Radzina M, de Soccio V, Elia D, De Felice C, Pediconi F, Gigli S, Occhiato R, Messineo D, Fresilli D, Ballesio L, D'Ambrosio F. US-Elastography for Breast Lesion Characterization: Prospective Comparison of US BIRADS, Strain Elastography and Shear wave Elastography. Ultraschall Med. 2021 Oct;42(5):533-540. doi: 10.1055/a-1134-4937. Epub 2020 Apr 24.
PubMed 32330993Li X, Sun W, Zhang H. The value of elastography strain rate ratio in benign and malignant BI-RADS-US 3-4 breast masses. Biomol Biomed. 2024 May 2;24(3):625-632. doi: 10.17305/bb.2023.9878.
PubMed 38149832Mutala TM, Mwango GN, Aywak A, Cioni D, Neri E. Determining the elastography strain ratio cut off value for differentiating benign from malignant breast lesions: systematic review and meta-analysis. Cancer Imaging. 2022 Feb 12;22(1):12. doi: 10.1186/s40644-022-00447-5.
PubMed 35151365
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Strain Elastography in Characterization of Solid Breast Lesions.
- ClinicalTrials.gov ID
- NCT07649590
- Acronym / sponsor ID
- Sog-Med--24-12-08MS
- Conditions
- Solid Breast Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 16 Jun 2026 (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.
Breast lesions are a common concern in clinical practice, requiring accurate diagnostic tools for effective evaluation. Traditional imaging modalities, such as mammography and ultrasound, play critical roles in detecting and characterizing these lesions. However, the emergence of advanced techniques like strain elastography has significantly enhanced our ability to assess the mechanical properties of breast tissues, providing valuable insights beyond standard imaging. Strain elastography is a non-invasive ultrasound-based technique that evaluates tissue stiffness by measuring the degree of deformation in response to applied pressure. This technique capitalizes on the principle that malignant tissues are typically stiffer than benign ones, offering a potential method for differentiating between solid breast lesions. By assessing the elastic properties of breast tissues, strain elastography aids in improving diagnostic accuracy and reducing the need for unnecessary biopsies.
The diagnostic value of strain elastography lies in its ability to provide real-time feedback during ultrasound examinations. This immediacy allows clinicians to make informed decisions about further management based on the mechanical characteristics of the lesions. The integration of strain elastography into routine breast imaging protocols can enhance the specificity and sensitivity of lesion characterization, ultimately benefiting patient outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Woman aged 18 years or older. * Having solid breast lesions identified through mammography or ultrasound and who are scheuduled for biopsy
Key inclusion criteria (2 listed)
- Woman aged 18 years or older.
- Having solid breast lesions identified through mammography or ultrasound and who are scheuduled for biopsy
Key exclusion criteria (3 listed)
- Patient with proor breast surgeries
- patient who had alocalzied systemic diseases that prevents biopsy.
- Inflammtory conditions
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 |
|---|---|---|
| Ultrasoundexamination by Ultrasound | Radiation | – |
Primary outcome
Assessment of the mass harness by elastography
Time frame: one year
assessmnet of the mass harness by elasography ration E2/E1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 32330993Cantisani V, David E, Barr RG, Radzina M, de Soccio V, Elia D, De Felice C, Pediconi F, Gigli S, Occhiato R, Messineo D, Fresilli D, Ballesio L, D'Ambrosio F. US-Elastography for Breast Lesion Characterization: Prospective Comparison of US BIRADS, Strain Elastography and Shear wave Elastography. Ultraschall Med. 2021 Oct;42(5):533-540. doi: 10.1055/a-1134-4937. Epub 2020 Apr 24.
- Background: PubMed 38149832Li X, Sun W, Zhang H. The value of elastography strain rate ratio in benign and malignant BI-RADS-US 3-4 breast masses. Biomol Biomed. 2024 May 2;24(3):625-632. doi: 10.17305/bb.2023.9878.
- Background: PubMed 35151365Mutala TM, Mwango GN, Aywak A, Cioni D, Neri E. Determining the elastography strain ratio cut off value for differentiating benign from malignant breast lesions: systematic review and meta-analysis. Cancer Imaging. 2022 Feb 12;22(1):12. doi: 10.1186/s40644-022-00447-5.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Breast Lesions, run by Sohag University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the mass harness by elastography (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07649590, which also lists 3 linked publications.
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 16 Jun 2026.