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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Pilot Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography to Detect Breast Cancer in Patients With Increased Breast Density (Breast Imaging-Reporting And Data System (BI-RADS) Category c or d)

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Dual-Energy Contrast-Enhanced (DECE) mammography
* Device: digital mammography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent At least 19 years old Glomerular filtration rate> 60 Heterogeneously or extremely dense breasts (BI-RADS category c or d). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contrast enhanced mammography vs standard digital mammogram<br>Contrast-enhanced spectral mammography for the detection breast cancer . | Device: Dual-Energy Contrast-Enhanced (DECE) mammography<br>* Contrast mammography<br>* Other names: Contrast-enhanced mammography;Device: digital mammography<br>* routine digital mammography<br>* Other names: full field digital mammography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Accuracy of Contrast Mammography | •The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density). | 1 year | 
| Number of Participants With Cancer Detected | •The primary endpoint of this study is to detect the presence of cancer using DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (BI-RADS category c or d breast density). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Call Backs With Contrast Mammography | •The patients identified for additional imaging based on unconfirmed findings. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dual-energy contrast-enhanced digital mammography, breast cancer screening, dense breasts