Breast Neoplasm Clinical Trial
Official title:
Patterns of Non-mass Enhancement of Breast MRI Using the BI-RADS Lexicon Fifth Edition With Histopathologic Correlation
Breast Magnetic Resonance Imaging (MRI) has been proven to be the most sensitive method in
detection of breast cancer with sensitivity reaching 68-100%. The most frequent indication
for breast MRI is screening for high-risk patients with a 20% or greater lifetime risk of
developing breast cancer. Other indications include; assessment of extent of disease and
screening of the contralateral breast in patients who are newly diagnosed with primary breast
cancer. Evaluation of residual disease post Breast Conserving Surgery (BCS) with positive
margins, loco-regional recurrence detection, as well as response to neoadjuvant chemotherapy
are also well visualized by breast MRI. Furthermore, assessment of inconclusive mammography
finding without a sonographic correlate, suspicious nipple discharge without a
sono-mammographic or galacto-graphic correlate and evaluation of metastatic axillary
lymphadenopathy in case of unknown primary tumor are all indications in which breast MRI has
shown high sensitivity.
Breast MRI also helps in identifying multifocal/multicentric or contralateral breast
malignancies which was not detected by conventional imaging. Moreover, MRI gives more
accurate data about local extension of invasive breast cancer and in situ tumors than other
conventional modalities. In some patients newly diagnosed to have cancer breast, breast MRI
is able to detect additional lesions that has not been found in mammography or breast
ultrasound in 6 - 34% in the ipsilateral breast and 3 - 5% in the contralateral breast. These
additional breast lesions are classified into focus, mass, and non-mass enhancement (NME) on
MRI.
Non-mass enhancement (NME) is defined as an enhancing abnormality that is not associated with
the three-dimension volume of a mass, shape and outlining, and they are separate from the
Background Parenchymal Enhancement (BPE). The fifth edition of the American College of
Radiology (ACR) Breast Imaging-Reporting and Data System (BI-RADS) lexicon has erased some
ambiguities, and modified terminologies from the fourth edition to provide more precise
evaluation in descriptions of the distribution and Internal Enhancement Patterns (IEPs) of
NME, contributes in quality assurance, better communication with physicians, and enhances
patient care.
For morphological assessment of NME, distribution is described as focal, linear, segmental,
regional, multiple regions, and diffuse. And the IEPs are characterized as homogeneous,
heterogeneous, clumped, and clustered ring. NME may be benign as Pseudoangiomatous Stromal
Hyperplasia (PASH), apocrine metaplasia and radiation effect; high risk such as Atypical
Ductal Hyperplasia (ADH), flat epithelial atypia, intraductal papilloma, radial scar or
complex sclerosing lesion, or malignant as Ductal Carcinoma in-situ (DCIS), Invasive Ductal
Carcinoma (IDC), and Invasive Lobular Carcinoma (ILC).
| Status | Not yet recruiting |
| Enrollment | 50 |
| Est. completion date | September 2021 |
| Est. primary completion date | March 2021 |
| Accepts healthy volunteers | |
| Gender | Female |
| Age group | 33 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - all female with mean age 50 ± 17 having breast MRI Exclusion Criteria: - Contraindications of MRI as pacemakers, aneurysmal clipping, retained metallic foreign bodies, or claustrophobic patients - Pregnant women especially in the first trimester. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University |
Chadashvili T, Ghosh E, Fein-Zachary V, Mehta TS, Venkataraman S, Dialani V, Slanetz PJ. Nonmass enhancement on breast MRI: review of patterns with radiologic-pathologic correlation and discussion of management. AJR Am J Roentgenol. 2015 Jan;204(1):219-27. doi: 10.2214/AJR.14.12656. Review. — View Citation
Cho YH, Cho KR, Park EK, Seo BK, Woo OH, Cho SB, Bae JW. Significance of Additional Non-Mass Enhancement in Patients with Breast Cancer on Preoperative 3T Dynamic Contrast Enhanced MRI of the Breast. Iran J Radiol. 2016 Jan 23;13(1):e30909. doi: 10.5812/iranjradiol.30909. eCollection 2016 Jan. — View Citation
D'Orsi CJ, Sickles EA, Mendelson EB, Morris EA, et al. ACR BI-RADS Atlas, Breast Imaging Reporting and Data System. Reston, VA, American College of Radiology; 2013.
Ha GW, Yi MS, Lee BK, Youn HJ, Jung SH. Clinical outcome of magnetic resonance imaging-detected additional lesions in breast cancer patients. J Breast Cancer. 2011 Sep;14(3):213-8. doi: 10.4048/jbc.2011.14.3.213. Epub 2011 Sep 29. — View Citation
Lee SM, Nam KJ, Choo KS, Kim JY, Jeong DW, Kim HY, Kim JY. Patterns of malignant non-mass enhancement on 3-T breast MRI help predict invasiveness: using the BI-RADS lexicon fifth edition. Acta Radiol. 2018 Nov;59(11):1292-1299. doi: 10.1177/0284185118759139. Epub 2018 May 14. — View Citation
Machida Y, Shimauchi A, Tozaki M, Kuroki Y, Yoshida T, Fukuma E. Descriptors of Malignant Non-mass Enhancement of Breast MRI: Their Correlation to the Presence of Invasion. Acad Radiol. 2016 Jun;23(6):687-95. doi: 10.1016/j.acra.2016.01.014. Epub 2016 Mar 11. — View Citation
Park SY, Han BK, Ko ES, Ko EY, Cho EY. Additional lesions seen in magnetic resonance imaging of breast cancer patients: the role of second-look ultrasound and imaging-guided interventions. Ultrasonography. 2019 Jan;38(1):76-82. doi: 10.14366/usg.18002. Epub 2018 Jun 23. — View Citation
Shin K, Phalak K, Hamame A, Whitman GJ. Interpretation of Breast MRI Utilizing the BI-RADS Fifth Edition Lexicon: How Are We Doing and Where Are We Headed? Curr Probl Diagn Radiol. 2017 Jan - Feb;46(1):26-34. doi: 10.1067/j.cpradiol.2015.12.001. Epub 2015 Dec 15. Review. — View Citation
Yang QX, Ji X, Feng LL, Zheng L, Zhou XQ, Wu Q, Chen X. Significant MRI indicators of malignancy for breast non-mass enhancement. J Xray Sci Technol. 2017;25(6):1033-1044. doi: 10.3233/XST-17311. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patterns of non-mass enhancement on breast MRI | To estimate the various patterns of NME using the BI-RADS lexicon fifth edition with histopathologic correlation; to evaluate their clinical significance. | Within one year; from March 2020 to March 2021 |
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