Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (BI-RADS category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer.

Key facts

Study ID

NCT02995980

Run by

University of Alabama at Birmingham

People needed

128

Starts

2015-11-01

Expected to finish

2018-05-31

Last updated by the study team

2019-09-25

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Signed informed consent
• At least 19 years old
• Glomerular filtration rate> 60
• Heterogeneously or extremely dense breasts (BI-RADS category c or d).

You may not qualify if…

• History of iodinated contrast allergy
• Pregnant or lactating as determined by routine standard practice
• Personal history of breast cancer
• History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded)
• History of prior breast reduction mammoplasty surgery
• History of prior breast augmentation surgery
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

Where it is running

• The Kirklin Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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