Adding MRI diffusion and mammogram micro‑calcifications to the Kaiser Score for BI-RADS 4 breast lesions
Official title: Diagnostic Performance of Combining Apparent Diffusion Coefficient and Micro-calcifications to Kaiser Score in Evaluation of BI-RADS 4 Breast Lesions
Run by Mansoura University Hospital · NCT07033507 · Data updated 2026-11-12
This project will test whether adding MRI diffusion measurements and mammogram micro‑calcification findings to the Kaiser Score can better identify which BI‑RADS 4 breast lesions need a biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | Mansoura University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Al Mansurah) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | October 1, 2025 |
| Study ends | January 1, 2026 |
| Registry record updated | June 24, 2025 |
| Trial ID | NCT07033507 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People with BI‑RADS 4 breast lesions who can undergo mammography and MRI (no MRI contraindications) and who have not started chemotherapy are ideal candidates.
✕Probably not a fit
Patients with MRI contraindications (pacemakers, cochlear implants, ocular foreign bodies, severe claustrophobia) or those already receiving chemotherapy are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll patients with BI‑RADS 4 breast lesions and collect mammography and breast MRI including diffusion‑weighted imaging (diffusion coefficient/ADC). Investigators will calculate the Kaiser Score for each lesion and record the presence and characteristics of micro‑calcifications on mammography. Imaging results will be compared with pathology from biopsy to see if adding diffusion metrics and micro‑calcification data improves diagnostic accuracy and reduces inter‑reader variability. Patients with MRI contraindications or on chemotherapy are excluded.
Why it matters
Potential benefit: If successful, this approach could lower unnecessary biopsies and improve detection of ductal carcinoma in situ by combining MRI diffusion data and mammography features with the Kaiser Score.
How similar studies have gone: Previous studies show the Kaiser Score and diffusion‑weighted MRI individually help distinguish benign from malignant lesions and that suspicious micro‑calcifications can flag DCIS, but combining all three features has not been widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with BI-RADS 4 lesion. Exclusion Criteria: * Patients on chemotherapy or related treatment. * Patients who have contraindications to do MRI as patients with cardiac pace maker, patients with cochlear implant and ocular foreign body, claustrophobia.
Where it's running
-
Mohamed AbdElmoniem
Al Mansurah, Egypt Recruiting
Study contacts
- Principal investigator: Mohamed AbdElmoniem — Lecturer of faculty of medicine Mansoura university
- Study coordinator: Mohamed AbdElmoniem
- Email: dr.m1993@mans.edu.eg
- Phone: 01014008473
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.