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NCT Number: NCT07033507

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

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

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

Location status: Recruiting

Location contact

Maryam Hamdy foaud, lecturer

SUB_INVESTIGATOR

Mohamed AbdElmoniem

CONTACT

[email protected]

01014008473

About this study

A method with lower inter-reader variability for distinguishing benign lesions from BI-RADS 4 lesions needs to be developed to help avoiding unnecessary biopsies. The Kaiser score (KS) is a classification tree flowchart based on machine learning, which can guide clinical decision-making about breast imaging findings on breast MRI. It selects five morphological features and kinetics among 17 categorical diagnostic criteria to score each breast lesion and applies to both mass and non-mass enhancement (NME) lesions. The KS value ranges from 1 to 11, with increasing values indicating higher probability of malignancy. A biopsy is recommended, if the lesion score exceeds 4.

Ductal carcinoma in situ (DCIS), whose incidence has recently increased rapidly, only manifests as suspicious microcalcifications from time to time. Between 70% and 90% of DCIS diagnoses depend mainly on detecting microcalcifications on mammography.The morphology and distribution of microcalcifications are of great significance in distinguishing between benign and malignant micro calcifications. Given its confinement to the milk ducts, DCIS always presents as NME lesions and may be false-negative on MRI. A previous study suggested that the KS should be upgraded in the presence of suspicious mammographic microcalcifications to avoid missed DCIS diagnosis

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: 12 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maryam Hamdy foaud

CONTACT

[email protected]

01016881450

Mohamed AbdElmoniem

CONTACT

[email protected]

01014008473

Sponsors and collaborators

Lead sponsor

Mansoura University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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