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

NCT ID: NCT02995980

Last Updated: 2019-09-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-05-31

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

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Contrast enhanced mammography vs standard digital mammogram

Contrast-enhanced spectral mammography for the detection breast cancer .

Group Type EXPERIMENTAL

Dual-Energy Contrast-Enhanced (DECE) mammography

Intervention Type DEVICE

Contrast mammography

digital mammography

Intervention Type DEVICE

routine digital mammography

Interventions

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Dual-Energy Contrast-Enhanced (DECE) mammography

Contrast mammography

Intervention Type DEVICE

digital mammography

routine digital mammography

Intervention Type DEVICE

Other Intervention Names

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Contrast-enhanced spectral mammography (CESM) Contrast-enhanced mammography full field digital mammography

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Rachael Lancaster, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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F141210004

Identifier Type: -

Identifier Source: org_study_id

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