Non-mass Enhancement in Breast MRI

NCT04083027 | Completed FDA Device

• 1 other identifier: Breast MRI
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

MRI DEVICE

Breast MRI

Eligibility Criteria

• Age: 33 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with mean age 50 ± 17

You may qualify if:

• all female with mean age 50 ± 17 having breast MRI

You may not qualify if:

• Contraindications of MRI as pacemakers, aneurysmal clipping, retained metallic foreign bodies, or claustrophobic patients
• Pregnant women especially in the first trimester.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals

Asyut, 71515, Egypt

Location

Related Publications (9)

• 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.

  PMID: 30103597 BACKGROUND

• 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.

  PMID: 26826797 BACKGROUND

• 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.

  PMID: 22031803 BACKGROUND

• 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.

  PMID: 27127579 BACKGROUND

• 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.

  PMID: 29758996 BACKGROUND

• 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.

  PMID: 29154312 BACKGROUND

• 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.

  PMID: 26976623 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25539260 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 10, 2019
• Study Start: March 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

EG (1)