Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography
NCT ID: NCT02995980
Last Updated: 2019-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2015-11-30
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Contrast enhanced mammography vs standard digital mammogram
Contrast-enhanced spectral mammography for the detection breast cancer .
Dual-Energy Contrast-Enhanced (DECE) mammography
Contrast mammography
digital mammography
routine digital mammography
Interventions
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Dual-Energy Contrast-Enhanced (DECE) mammography
Contrast mammography
digital mammography
routine digital mammography
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
19 Years
FEMALE
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Rachael Lancaster, MD
MD
Principal Investigators
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Heidi R Umphrey, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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The Kirklin Clinic
Birmingham, Alabama, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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F141210004
Identifier Type: -
Identifier Source: org_study_id
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