Non Mass Breast LesionsNCT07679308
Diagnostic Accuracy of Multiparametric Dynamic Contrast Enhanced Magnetic Resonance Imaging in Improving Detection of Ultrasound Non-mass Breast Lesions According to ACR BI-RADS v2025
An observational study of Non Mass Breast Lesions, run by Sohag University.
Trial summary
this study aims To evaluate the diagnostic performance of Ultrasound (US) in correlation with Dynamic Magnetic Resonance Imaging (MRI) for the assessment, characterization, and evaluation of non-mass breast lesions. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Non Mass Breast Lesions
- What is being tested?
- multiparametric DCE- MRI and US for all patients
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jan 2028
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female patients of any age group presented with non mass lesions on either US or mammography
Who may be able to join
- • Female patients of any age presenting with non-mass breast lesions detected on MRI or conventional imaging.
- Patients who have both MRI and targeted Ultrasound examinations.
Who cannot join
- • Patients presenting with typical distinct "mass" lesions (3D space-occupying lesions) without any non-mass components.
- Patients with absolute contraindications to MRI (e.g., cardiac pacemakers, severe claustrophobia, non-compatible metallic implants).
- Patients with contraindications to intravenous Gadolinium contrast media (e.g., severe renal impairment/failure, pregnancy, known history of severe allergic reaction to gadolinium).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Alaa Nor Abdelghafar Nor Abdelghafar, Assistant Lecturer contact
About this study
this study aims To evaluate the diagnostic performance of Ultrasound (US) in correlation with Dynamic Magnetic Resonance Imaging (MRI) for the assessment, characterization, and evaluation of non-mass breast lesions.
The study will investigate whether DCE-MRI improves lesions detected by characterization and diagnostic accuracy when interpreted according to the ACR BIRADS v 2025 and so may help optimize breast imaging evaluation and support clinical decision making
Read the detailed description
- Background: Non-mass breast lesions detected by ultrasound may present diagnostic challenges because of their variable imaging appearances and overlap between benign and malignant findings.
- Objective: To evaluate the diagnostic performance of Ultrasound (US) in correlation with Dynamic Magnetic Resonance Imaging (MRI) for the assessment, characterization, and evaluation of non-mass breast lesions according to ACR BIRADS v 2025.
- Methods: This observational study will include patients with non-mass breast lesions identified on breast ultrasound or mammography. Participants will undergo breast MRI examination including dynamic contrast-enhanced sequences. Imaging findings will be assessed according to ACR BI-RADS 2025 criteria .
- Outcome Measures: The primary outcome will be the diagnostic performance of DCE-MRI, including sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy in differentiating benign from malignant lesions.
- Significance: The study aims to determine whether multiparametric DCE-MRI can improve characterization of ultrasound-detected non-mass breast lesions and support more accurate clinical decision-making.
- Conditions
- Non Mass Breast Lesions
- Being tested
- multiparametric DCE- MRI and US for all patients
- Keywords
- DCE Breast MRI, Non mass breast lesions, Breast US
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiparametric DCE- MRI and US for all patientsDiagnostic test
Multiparametric DCE-MRI performed for evaluation of non mass breast lesions detected on ultrasound , with assessment of diagnostic accuracy according to ACR BIRADS v 2025
| Study group | Role | What they receive |
|---|---|---|
| Patients with non mass breast lesions on US | Women with US detected non mass breast lesions undergoing DCE-MRI evaluation according to ACR- BIRADS v 2025 Receives: Diagnostic Test: multiparametric DCE- MRI and US for all patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of Multiparametric DCE-MRI in characterization of non mass breast lesions detected on Ultrasound
evaluation the diagnostic performance of Ultrasound (US) in correlation with Dynamic Magnetic Resonance Imaging (MRI) for the assessment, characterization, and evaluation of non-mass breast lesions.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Mass 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Nor Abdelghafar, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679308
- Sponsor's protocol ID
- Soh-Med--26-6-3MD
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Multiparametric Dynamic Contrast Enhanced Magnetic Resonance Imaging in Improving Detection of Ultrasound Non-mass Breast Lesions According to ACR BI-RADS v2025
- ClinicalTrials.gov ID
- NCT07679308
- Acronym / sponsor ID
- Soh-Med--26-6-3MD
- Conditions
- Non Mass Breast Lesions
- Keywords
- DCE Breast MRI, Non mass breast lesions, Breast US
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 1 Jul 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.
this study aims To evaluate the diagnostic performance of Ultrasound (US) in correlation with Dynamic Magnetic Resonance Imaging (MRI) for the assessment, characterization, and evaluation of non-mass breast lesions.
The study will investigate whether DCE-MRI improves lesions detected by characterization and diagnostic accuracy when interpreted according to the ACR BIRADS v 2025 and so may help optimize breast imaging evaluation and support clinical decision making
Detailed description
- Background: Non-mass breast lesions detected by ultrasound may present diagnostic challenges because of their variable imaging appearances and overlap between benign and malignant findings.
- Objective: To evaluate the diagnostic performance of Ultrasound (US) in correlation with Dynamic Magnetic Resonance Imaging (MRI) for the assessment, characterization, and evaluation of non-mass breast lesions according to ACR BIRADS v 2025.
- Methods: This observational study will include patients with non-mass breast lesions identified on breast ultrasound or mammography. Participants will undergo breast MRI examination including dynamic contrast-enhanced sequences. Imaging findings will be assessed according to ACR BI-RADS 2025 criteria .
- Outcome Measures: The primary outcome will be the diagnostic performance of DCE-MRI, including sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy in differentiating benign from malignant lesions.
- Significance: The study aims to determine whether multiparametric DCE-MRI can improve characterization of ultrasound-detected non-mass breast lesions and support more accurate clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with non mass breast lesions on US | – | Diagnostic Test: multiparametric DCE- MRI and US for all patientsWomen with US detected non mass breast lesions undergoing DCE-MRI evaluation according to ACR- BIRADS v 2025 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients of any age group presented with non mass lesions on either US or mammography
Key inclusion criteria (2 listed)
- • Female patients of any age presenting with non-mass breast lesions detected on MRI or conventional imaging.
Key exclusion criteria (3 listed)
- • Patients presenting with typical distinct "mass" lesions (3D space-occupying lesions) without any non-mass components.
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 |
|---|---|---|
| multiparametric DCE- MRI and US for all patientsMultiparametric DCE-MRI performed for evaluation of non mass breast lesions detected on ultrasound , with assessment of diagnostic accuracy according to ACR BIRADS v 2025 | Diagnostic test | Patients with non mass breast lesions on US |
Primary outcome
Diagnostic accuracy of Multiparametric DCE-MRI in characterization of non mass breast lesions detected on Ultrasound
Time frame: 8 months
evaluation the diagnostic performance of Ultrasound (US) in correlation with Dynamic Magnetic Resonance Imaging (MRI) for the assessment, characterization, and evaluation of non-mass breast lesions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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.
Alaa Nor Abdelghafar Nor Abdelghafar, Assistant Lecturer contact
Questions about this trial
What is this clinical trial studying?
An observational study of Non Mass Breast Lesions, run by Sohag 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 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: opening soon, as of the sponsor's last update on 1 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa Nor Abdelghafar Nor Abdelghafar, Assistant Lecturer (01063550892, alaa011053@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of Multiparametric DCE-MRI in characterization of non mass breast lesions detected on Ultrasound (time frame: 8 months). 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 1 Jul 2026.