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Breast NeoplasmNCT04083027

Non-mass Enhancement in Breast MRI

An observational study of Breast Neoplasm, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 33 to 70 years, women only
Conditions the study is for
Breast Neoplasm
What is being tested?
MRI
Type of treatment
Medical device
How many people
66 participants
Where
1 siteEgypt
Study dates
1 Mar 2020to 1 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 33 to 70 years
  • Women only
  • Adult, Older adult

Study population: Female patients with mean age 50 ± 17

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut University Hospitals

    Asyut, 71515

Other trials in Egypt

About this study

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.

Read more

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
Being tested
MRI
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIDevice

    Breast MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within one year; from March 2020 to March 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2019
  2. Study start1 Mar 2020
  3. Primary completion1 Mar 2021
  4. Study completion1 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04083027
Sponsor's protocol ID
Breast MRI
Status last verified
Oct 2024
First submitted
6 Sep 2019
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30103597

  • 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.

    PubMed 26826797

  • 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.

    PubMed 22031803

  • 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.

    PubMed 27127579

  • 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.

    PubMed 29758996

  • 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.

    PubMed 29154312

  • 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.

    PubMed 26976623

  • 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.

  • 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.

    PubMed 25539260

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasm, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patterns of non-mass enhancement on breast MRI (time frame: Within one year; from March 2020 to March 2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04083027, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.

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