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Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening
The purpose of this study is to evaluate how well women may adopt a Contrast-enhanced Spectral Mammography (CESM) as their yearly breast screening test compared to the standard 2-D or 3-D mammogram.
Conditions:
🦠 Mammographic Breast Density 🦠 Mammography
🗓️ Study Start (Actual) 19 September 2019
🗓️ Primary Completion (Estimated) December 2022
✅ Study Completion (Estimated) June 2023
👥 Enrollment (Estimated) 210
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Charlottesville, Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * • Female
    • * 40 to 69 years
    • * Previous normal mammogram (BI-RADS 1 or 2) showing heterogeneous or extremely dense breast tissue within last 24 months
    • * Scheduled for screening mammogram as part of the patient's clinical care

    Exclusion Criteria:

    • * • No mammogram within last 24 months
    • * Fatty or scattered fibroglandular tissue on last mammogram
    • * History of allergy to iodinated contrast
    • * History of renal disease or renal function abnormalities
    • * Pregnant women
    • * History of diabetes
    • * History of paraproteinemia syndromes such as multiple myeloma
    • * History of collagen vascular disease
    • * History of vascular disease (coronary artery disease, myocardial infarction, carotid disease, peripheral vascular disease, or known visceral artery disease)
    • * Previously identified as high risk for breast cancer (\>20% lifetime risk)
    • * Asthma
    • * Sickle Cell Anemia
    • * Currently on Dialysis
Ages Eligible for Study: 40 Years to 69 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 February 2021
  • First Submitted that Met QC Criteria 24 May 2021
  • First Posted 27 May 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 November 2022
  • Last Update Posted 17 November 2022
  • Last Verified November 2022
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