Adding MRI diffusion and mammogram micro‑calcifications to the Kaiser Score for BI-RADS 4 breast lesions
Diagnostic Performance of Combining Apparent Diffusion Coefficient and Micro-calcifications to Kaiser Score in Evaluation of BI-RADS 4 Breast Lesions
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 |
|---|---|
| Enrollment | 80 (estimated) |
| Sex | Female |
| Sponsor | Mansoura University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Al Mansurah) |
| Trial ID | NCT07033507 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Al Mansurah
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.