NCT02995980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 25, 2019

Completed
Last Updated

September 25, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

March 20, 2016

Results QC Date

July 23, 2019

Last Update Submit

August 30, 2019

Conditions

Breast Cancer

Keywords

breast cancer screeningdense breastsdual-energy contrast-enhanced digital mammography

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Number of Call Backs With Contrast Mammography

    1 year

Study Arms (1)

Contrast enhanced mammography vs standard digital mammogram

EXPERIMENTAL

Contrast-enhanced spectral mammography for the detection breast cancer .

Device: Dual-Energy Contrast-Enhanced (DECE) mammographyDevice: digital mammography

Interventions

Dual-Energy Contrast-Enhanced (DECE) mammographyDEVICE

Contrast mammography

Also known as: Contrast-enhanced spectral mammography (CESM), Contrast-enhanced mammography
Contrast enhanced mammography vs standard digital mammogram
digital mammographyDEVICE

routine digital mammography

Also known as: full field digital mammography
Contrast enhanced mammography vs standard digital mammogram

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • At least 19 years old
  • Glomerular filtration rate\> 60
  • Heterogeneously or extremely dense breasts (BI-RADS category c or d).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Kirklin Clinic

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Rachael Lancaster, MD
Organization
University of Alabama at Birmingahm
mvetrano@uabmc.edu
205-934-4080

Study Officials

  • Heidi R Umphrey, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 20, 2016

First Posted

December 19, 2016

Study Start

November 1, 2015

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

September 25, 2019

Results First Posted

September 25, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)