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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual-Energy Contrast-Enhanced (DECE) mammography
digital mammography
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer screening, dense breasts, dual-energy contrast-enhanced digital mammography

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • The Kirklin Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contrast enhanced mammography vs standard digital mammogram

Arm Description

Contrast-enhanced spectral mammography for the detection breast cancer .

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Number of Call Backs With Contrast Mammography
•The patients identified for additional imaging based on unconfirmed findings.

Full Information

First Posted
March 20, 2016
Last Updated
August 30, 2019
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02995980
Brief Title
Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer screening, dense breasts, dual-energy contrast-enhanced digital mammography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contrast enhanced mammography vs standard digital mammogram
Arm Type
Experimental
Arm Description
Contrast-enhanced spectral mammography for the detection breast cancer .
Intervention Type
Device
Intervention Name(s)
Dual-Energy Contrast-Enhanced (DECE) mammography
Other Intervention Name(s)
Contrast-enhanced spectral mammography (CESM), Contrast-enhanced mammography
Intervention Description
Contrast mammography
Intervention Type
Device
Intervention Name(s)
digital mammography
Other Intervention Name(s)
full field digital mammography
Intervention Description
routine digital mammography
Primary Outcome Measure Information:
Title
Percent Accuracy of Contrast Mammography
Description
•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).
Time Frame
1 year
Title
Number of Participants With Cancer Detected
Description
•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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of Call Backs With Contrast Mammography
Description
•The patients identified for additional imaging based on unconfirmed findings.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi R Umphrey, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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