Non-mass Enhancement in Breast MRI

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04083027
Collaborator
(none)
50
18

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: MRI

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Patterns of Non-mass Enhancement of Breast MRI Using the BI-RADS Lexicon Fifth Edition With Histopathologic Correlation
Anticipated Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Patterns of non-mass enhancement on breast MRI [Within one year; from March 2020 to March 2021]

    To estimate the various patterns of NME using the BI-RADS lexicon fifth edition with histopathologic correlation; to evaluate their clinical significance.

Eligibility Criteria

Criteria

Ages Eligible for Study:
33 Years to 70 Years
Sexes Eligible for Study:
Female
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sara Mohamed Gamal Hassan, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04083027
Other Study ID Numbers:
  • Breast MRI
First Posted:
Sep 10, 2019
Last Update Posted:
Sep 12, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 12, 2019