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Completed

NCT Number: NCT02995980

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Kirklin Clinic

Birmingham, Alabama, 35294, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dual-Energy Contrast-Enhanced (DECE) mammography

Device

Contrast mammography

Other names: Contrast-enhanced spectral mammography (CESM), Contrast-enhanced mammography

digital mammography

Device

routine digital mammography

Other names: full field digital mammography

Primary outcomes

  1. Percent Accuracy of Contrast Mammography

    Time frame: 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).

  2. Number of Participants With Cancer Detected

    Time frame: 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 outcomes

  1. Number of Call Backs With Contrast Mammography

    Time frame: 1 year

    •The patients identified for additional imaging based on unconfirmed findings.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2016
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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