Diffusion Coefficient and Micro-calcifications to Kaiser Score in Evaluation of BI-RADS 4 Breast Lesions

NCT07033507 | Recruiting

• 1 other identifier: MD.24.04.846
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Neoplasms

Keywords

BI-RADS 4 breast lesions; diffusion coefficient; micro-calcifications; Kaiser Score

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of combining apparent diffusion coefficient and micro-calcifications to Kaiser Score in evaluation of BI-RADS 4 breast lesions

  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.

  12 months

Study Arms (1)

BI-RADS 4 breast lesions

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.

Diagnostic Test: MRI diffusion coefficient and micro-calcifications to Kaiser Score in evaluation of BI-RADS 4 breast lesions

Interventions

MRI diffusion coefficient and micro-calcifications to Kaiser Score in evaluation of BI-RADS 4 breast lesions DIAGNOSTIC_TEST

Compare MRI diffusion coefficient and micro-calcifications to Kaiser Score in evaluation of BI-RADS 4 breast lesions

BI-RADS 4 breast lesions

Eligibility Criteria

• Gender Eligibility Details: Evaluation of BI-RADS 4 breast lesions
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients will give age, Menstrual status and hormonal contraceptive use. Past and family history of breast cancer. Local breast and Axillary lymph nodes examination Imaging: MRI will be performed for BIRADS 4 lesions. Mammography will be performed for assessment of the presence of microcalcifications. Measurement of ADC value. Using the Kaiser score to re-evaluate BI-RADS 4 lesions, combined microcalcifications with Kaiser Score, combined ADC with Kaiser score. Mammography protocol: cranio-caudal and medio-lateral oblique. MRI protocol: using a 1.5 T magnet using a breast coil and will be done between 7th -14th days of the menstrual cycle. Dynamic post-contrast study Axial T1-fast spin echo Axial T2-fast spin echo Axial and coronal T2-inversion recovery

You may qualify if:

• Patients with BI-RADS 4 lesion.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mohamed AbdElmoniem

  Lecturer of faculty of medicine Mansoura university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed AbdElmoniem

CONTACT

01014008473; dr.m1993@mans.edu.eg

Maryam Hamdy foaud

CONTACT

01016881450; Maryamhamdy@mans.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer faculty of medicine

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 24, 2025
• Study Start: June 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

EG (1)