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NCT06089148 Clinical Trial

New Mammographic Techniques Versus MRI in Assessment of Breast Lesions

Breast Diseases Clinical Trial

— CEDM&DBTVSMR  

Official title:
Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast Lesions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06089148
Other study ID # 141014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2015
Est. completion date December 2016

Study information
Verified date October 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast lesions

Description:

Combined use of contrast-enhanced digital mammography (CEDM), and digital breast tomosynthesis (DBT), may be a reasonable alternative to MRI.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion criteria 1. Breast Imaging Reporting and Data System (BI-RADS) 3, 4, and 5 breast lesions. 2. Clinical indication for MRI breast imaging. 3. No histologically proven cancer before enrollment. Exclusion criteria 1. Pregnancy or possible pregnancy. 2. History of allergy to an iodinated contrast agent. 3. Renal impairment. 4. Contraindication for MRI examination

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• contrast enhanced digital mammography, tomosyntheis and MRI

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary sensitivity, specificity of'tomosynthesis and contrast enhanced mammography and MRI breast are measured in assessment of breast lesions and their pre-operative assessment of breast cancer diagnostic 1year
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