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Clinical Trials/NCT03696147
NCT03696147UnknownNot Applicable

Role of Diffusion Magnetic Resonance Imaging in Assessment of Mammographically Detected Asymmetric Densities

Assiut University0 sites50 target enrollmentStarted: December 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Primary Endpoint
Comparison of diffusion MRI finding with the pathology of the specimens

Study Overview

Brief Summary

The aim of the study is to identify the role of diffusion weighted MRI in the assessment of the clinical significance and outcomes of asymmetric breast densities identified on mammograms, and to identify the inconclusive mammographic findings most frequently associated with occult breast carcinoma.

Detailed Description

Although there is clearly a wide variation in breast size and parenchymal pattern, the breasts are generally symmetric structures with similar density and architecture. However, asymmetric breast tissue is encountered relatively frequently.

Asymmetric breast tissue is usually benign and secondary to variations in normal breast tissue, postoperative change from a previous biopsy, hormone replacement therapy , or merely poor positioning. However, an asymmetric area may indicate a developing mass or an underlying cancer.

The American College of Radiology (ACR), Breast Imaging Reporting and Data System (BI-RADS) defined four different types of asymmetric breast findings:

  1. Asymmetric Breast tissue: refers to a greater volume or density of breast tissue in one breast than in the corresponding area in the contra lateral breast.
  2. Densities seen in one projection: reflect a density seen in only one mammographic projection.
  3. Architectural distortion: refers to a focal area of breast tissue that appears distorted with no definable central mass. Speculations radiate from a common point, and there is an area of focal retraction and tethering of normal parenchyma.
  4. Focal asymmetric densities: refer to focal asymmetric densities that are seen on two mammographic views but cannot be accurately identified as a true mass.

These lesions are frequently encountered at screening and diagnostic mammography and are significant because they may indicate a neoplasm, especially if an associated palpable mass is present. Once these lesions are detected at standard mammography, supplementary breast imaging with additional mammographic views and ultrasonography (US) can be a key aspect of work-up.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All patients presented with asymmetric breast densities, seen on screening or diagnostic mammograms.

Exclusion Criteria

  • Patients with cardiac pacemakers.
  • Patients with brain aneurysm clips.
  • Patients with cochlear implants.
  • Patients with vascular stents.
  • Claustrophobic.

Outcomes

Primary Outcomes

Comparison of diffusion MRI finding with the pathology of the specimens

Time Frame: Baseline

Analysis of diffusion weighted images and ADC values to defferntiate different pathologies causing asymmetric densities in routine screening or diagnostic mammography

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shimaa Ali Saad

Assistant lecturer

Assiut University

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