CE-MRI&CESM in Solid Breast Lesions

Breast Neoplasms Clinical Trial

Official title:

1.3 Role of Contrast-enhanced Mammography and Dynamic Contrast-enhanced MRI in the Assessment of Solid Breast Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04832191
• Other study ID #: CE-MRI&CESM in breast lesions
• Status: Not yet recruiting
• Start date: April 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: April 2021
• Source: Assiut University
• Contact: Basma Fawzy Mohamed, assistant lecturer
• Phone: 01146393169
• Email: bfawzy1[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Our study aimed to assess the accuracy of CE-SM in comparison to contrast-enhanced breast MRI in the evaluation of solid breast lesions.

Description:

Breast cancer is the most common cancer in women, responsible for 23% of cancer in females worldwide (1). Early detection and accurate diagnosis of breast cancer aims to reduce morbidity and mortality and have essential role in management and improved prognosis of breast cancer (2). Mammography has been established as the imaging modality for screening and early detection of breast cancer; however, it is accused of having low sensitivity and specificity in women with dense breasts (3). Contrast-enhanced MRI considered the gold standard method for diagnosis of breast cancer; but, it has many limitations as high cost, long examination time and limited availability (4,5). Contrast-enhanced spectral mammogram (CESM) is considered now a relatively new imaging modality which can provide both anatomic and functional information of the breast lesion similar to MRI (6). CESM like contrast-enhanced MRI (CE-MRI) is used to detect angiogenesis of the lesion in the mammography suite. It includes high- and low-energy images during a single compression after contrast injection (7). The advantage of CESM over MRI is that it is less expensive and easier to perform with shorter examination time. Also, the higher sensitivity of MRI is plagued by numerous false-positive foci of enhancement (8). Also, CESM can replace MRI in case of patient contraindicating for MRI as patients with pacemakers, aneurysm clips or metal implants, or severe claustrophobia (7). So, our study aims to determine the value of CESM and answer the question of does CESM could replace CE-MRI in diagnosing breast cancer? so,our study aimed to assess the accuracy of CESM in comparison to contrast-enhanced breast MRI in the evaluation of solid breast lesions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who have previously undergone mammography (MG) and ultrasound and have a solid (BIRADs III and more) breast lesion.

Exclusion Criteria:

• Cystic breast lesions
• BIRADs I and II breast lesions(benign)
• Pregnancy
• History of allergic reaction to iodinated contrast agent
• Renal insufficiency
• Other contraindications to MRI include pacemaker, claustrophobia or metal prosthesis.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Device:
• CE-SM
contrast enhanced spectral mammography &contrast enhanced magnetic resonance imaging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Li L, Roth R, Germaine P, Ren S, Lee M, Hunter K, Tinney E, Liao L. Contrast-enhanced spectral mammography (CESM) versus breast magnetic resonance imaging (MRI): A retrospective comparison in 66 breast lesions. Diagn Interv Imaging. 2017 Feb;98(2):113-123. doi: 10.1016/j.diii.2016.08.013. Epub 2016 Sep 26. — View Citation

Zhu X, Huang JM, Zhang K, Xia LJ, Feng L, Yang P, Zhang MY, Xiao W, Lin HX, Yu YH. Diagnostic Value of Contrast-Enhanced Spectral Mammography for Screening Breast Cancer: Systematic Review and Meta-analysis. Clin Breast Cancer. 2018 Oct;18(5):e985-e995. doi: 10.1016/j.clbc.2018.06.003. Epub 2018 Jun 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison between accuracy of CESM and CE-MRI in diagnosing breast cancer.	Measurement of sensitivity, specificity and predictive values of CESM and CE-MRI in diagnosing breast cancer.	baseline