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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Dual-Energy Contrast-Enhanced (DECE) mammography; Device: digital mammography

• Registration Number: NCT02995980
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-03-20
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-19
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Results First Submitted: 2019-07-23
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-30
• Last Update Submitted: 2019-08-30
• Results First Posted: 2019-09-25
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast enhanced mammography vs standard digital mammogram	Dual-Energy Contrast-Enhanced (DECE) mammography	Contrast-enhanced spectral mammography for the detection breast cancer .
Contrast enhanced mammography vs standard digital mammogram	digital mammography	Contrast-enhanced spectral mammography for the detection breast cancer .

Primary Outcome Measures

Name	Time	Method
Percent Accuracy of Contrast Mammography	1 year	•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).
Number of Participants With Cancer Detected	1 year	•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).

Secondary Outcome Measures

Name	Time	Method
Number of Call Backs With Contrast Mammography	1 year	•The patients identified for additional imaging based on unconfirmed findings.

Trial Locations

Locations (1)

The Kirklin Clinic; 🇺🇸 Birmingham, Alabama, United States