RecruitingNot ApplicableNCT04871139

An Imaging Technology, Contrast-Enhanced Mammography, in Predicting Breast Cancer

Contrast-Enhanced Mammography (CEM) for the Evaluation and Targeted Biopsy of Suspicious Mammographic Architectural Distortions


Sponsor

M.D. Anderson Cancer Center

Enrollment

100 participants

Start Date

Apr 8, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial examines a new imaging technology, contrast-enhanced mammography, in predicting breast cancer. Contrast-enhanced mammography is similar to standard mammography, but it includes an intravenous (by vein) injection of iodine-based contrast, which makes tissue and blood vessels more visible in scans. Contrast-enhanced mammography may work better in detecting cancer in the breast that is not seen on other imaging tests and may help doctors find the most suspicious areas of the breast to biopsy, which could increase the chances of finding breast cancer.


Eligibility

Min Age: 25 YearsMax Age: 85 Years

Inclusion Criteria3

  • Women with suspicious MADs recommended for a stereotactic biopsy who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their biopsy at MDACC
  • Age 25-85 years
  • Willing to participate in the study, undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent

Exclusion Criteria6

  • Reported history of an allergic reaction to iodinated contrast
  • History of anaphylactic reaction to any substance
  • Renal insufficiency
  • Pregnancy or lactation within 6 months
  • Breast surgery affecting the site of interest within prior 6 months
  • Breast biopsy at the site of interest within the last 2 months

Interventions

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREContrast-Enhanced Mammography

Undergo CEM

OTHERQuestionnaire Administration

Ancillary studies

OTHERRadioactive Iodine

Given IV


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04871139


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