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

The University of Alabama at Birmingham

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Dual-Energy Contrast-Enhanced (DECE) mammography; Device: digital mammography

Study type: Interventional

Funder types: Other

Identifiers

NCT02995980

F141210004

Details and patient eligibility

About

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.

Full description

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 (Breast Imaging-Reporting And Data System 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

Enrollment: 128 patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 1 patient group

Contrast enhanced mammography vs standard digital mammogram

Experimental group

Description:

Contrast-enhanced spectral mammography for the detection breast cancer .

Treatment:

Device: digital mammography

Device: Dual-Energy Contrast-Enhanced (DECE) mammography