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OpenTrials
Completed

NCT Number: NCT02310698

Comparison of Whole Breast Screening Ultrasound and Contrast Enhanced Mammography for Supplemental Breast Cancer Screening

Breast tumors are often detected on mammography but may be harder to see in women with dense breasts. This is why screening breast ultrasound is sometimes used as another test in women with dense breasts. Ultrasound has been shown to detect additional cancers that are not seen on regular mammography.

Contrast Enhanced Digital Mammography (CEDM) is a FDA approved form of mammography. It is essentially a routine digital mammogram performed after iodine dye (the same that is used with CT scans) is injected into a vein in the arm. Like screening ultrasound, CEDM has been shown to detect breast cancers that are not seen on a regular mammogram. The purpose of this study is to compare whether CEDM or screening breast ultrasound is better at detecting cancer. Both will be done in this study and compared to one another.

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Key information

Conditions

Breast Cancer Screening

Age range

30 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other
  • Women scheduled for screening CEDM alone
  • Women scheduled for WBUS and screening CEDM on the same day or within 30 days of one another

Exclusion criteria

  • Age < 30 years old
  • Male patients
  • Patients with any clinical breast symptoms (palpable mass, nipple discharge, etc)
  • Patients with known diagnosis of breast cancer
  • Patients with any breast surgery or biopsy within 90 days prior to the study
  • Patients who have had a lumpectomy for breast cancer within 18 months prior to the study
  • Patients who are thought to have a breast MRI within 1 year prior to the study
  • Patients with contraindication to the intravenous use of iodinated contrast agent (i.e. allergy to iodinated contrast or severely impaired renal function with a creatinine level ≥1.3)

Treatment and study plan

contrast enhanced digital mammography (CEDM)

Device

whole breast screening ultrasound (WBUS)

Device

Primary outcomes

  1. The number of cancers and false positive findings identified on a CEDM and WBUS as a measure of sensitivity and specificity.

    Time frame: 1 year

    With respect to imaging, a positive test is defined by a recommendation for biopsy (BIRADS 4 or 5). Negative imaging tests are those with BIRADS 1-3. The number of recommendations for short term follow up (BI-RADS 3) will also be recorded.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2014
Registry last updated
Mar 28, 2025

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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