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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorMansoura University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with BI-RADS 4 lesion.

Disqualifiers

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.

Trial 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

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: BI-RADS 4 breast lesions1 intervention

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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