Diffusion Coefficient and Micro-calcifications to Kaiser Score in Evaluation of BI-RADS 4 Breast Lesions
Observational
Phase not listed
Mohamed AbdElmoniem
Sponsor: Mansoura University Hospital
Last Updated: June 24, 2025 Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.
Breast cancer is the most commonly diagnosed cancer worldwide and is the leading cause of cancer-related deaths in women. Mammography, breast ultrasonography (US), and breast magnetic resonance imaging (MRI) are essential for the diagnosis and follow-up of breast cancer. The American College of Radiology Breast Imaging- Reporting and Data System (ACR BI-RADS), which is used worldwide, provides the standard terminology for breast imaging (Jajodia et al., 2021). The ACR BI- RADS lexicon categorizes breast imaging findings into seven BIRADS categories of 0, 1, 2, 3, 4(4a, 4b, 4c), 5, and 6 according to the probability of malignancy. Breast imaging findings assigned as BI-RADS 4 require tissue sampling and histopathological examination. However, the likelihood of malignancy of lesions classified as BI-RADS 4 ranges widely, from 3% to 94%. Categorization of lesions according to BI-RADS is related to the experience of the radiologist, with experienced radiologists performing better than inexperienced radiologists
* Patients who have contraindications to do MRI as patients with cardiac pace maker, patients with cochlear implant and ocular foreign body, claustrophobia.
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Design Details
AllocationN/A
Intervention ModelN/A
MaskingN/A
Number to Enroll80
Arms & Interventions
Arms
Interventions
Type: N/A
Description: evaluate the reliability of ADC and micro calcifications (when present) in combination with the Kaiser score in improving the accuracy of the evaluation of BI- RADS 4 lesions and helping avoidance of unnecessary biopsies.
Interventions:
MRI diffusion coefficient and micro-calcifications to Kaiser Score in evaluation of BI-RADS 4 breast lesions
Outcome Measures
Primary Outcome Measures
Diagnostic performance of combining apparent diffusion coefficient and micro-calcifications to Kaiser Score in evaluation of BI-RADS 4 breast lesions12 months
evaluate the reliability of ADC and micro calcifications (when present) in combination with the Kaiser score in improving the accuracy of the evaluation of BI- RADS 4 lesions and helping avoidance of unnecessary biopsies.