Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03696147 |
| Other study ID # |
DWI breast cancer |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2018 |
| Est. completion date |
October 2019 |
Study information
| Verified date |
October 2018 |
| Source |
Assiut University |
| Contact |
Shimaa Ali Saad, Master |
| Phone |
+201022669516 |
| Email |
drshima15[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
However, these techniques may be insufficient to make a final BI-RADS assessment and may have
limited sensitivity and specificity for the detection and diagnosis of breast lesions,
yielding equivocal results. Certainty of the presence or absence of a true lesion can be
difficult, and the findings remain inconclusive. Moreover, Architectural distortion should
always be regarded with suspicion but differentiation from summation artifact is problematic.
Developing asymmetric densities need to be evaluated unless they can be explained in terms of
benign causes.
In these situations, MRI can be performed as an additional problem- solving procedure.
Positive MRI examination will prompt biopsy and allow for the timely detection of
malignancies that may otherwise would gone undiagnosed, while a negative MRI will allow
increased confidence that the equivocal finding was likely caused by summation artifact or
benign tissue , so follow-up surveillance mammography without biopsy will be undergone.
Although conventional breast MRI has a high sensitivity (89-100%) in the characterization of
breast lesions . However, an overlap between benign and malignant findings still persists,
resulting in a variable specificity (50-90%).
The DWI derives images from the difference of water molecules motion (Brownian motion) in
tissues, resulting in quantitative and qualitative data reflecting changes at the cellular
level and, consequently, unique information on the tumor cellularity and cell membranes
integrity. This would allow the increase in breast MRI specificity and reduction of
false-positive results and unnecessary biopsies.
Cell density might play an important role in the different ADCs obtained from benign and
malignant breast lesions and the measurement of extracellular water content may be an
additional feature that can improve MRI specificity.
The main objectives in using diffusion sequences are to optimize characterization of lesions
differentiating benign from malignant tumors; and to improve detection of small lesions,
which requires an optimal signal-to-noise ratio. several authors have shown that this
technique is relevant for smaller masses (5 mm) and even for non-mass like enhancements.
