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

August 3, 2023 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

487

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

MSKCC clinic

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Cancer Screening Patients

  • Women presenting for screening full field digital mammography (FFDM) and WBUS on the same day or within 30 days of one another.

    o These women will be offered CEDM instead of the FFDM.

  • Women that are scheduled for CEDM alone.

    o These women will be offered WBUS in addition to the CEDM.

  • Women scheduled for both CEDM and WBUS on the same day or within 30 days of one another.
Device: contrast enhanced digital mammography (CEDM)
Device: whole breast screening ultrasound (WBUS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Janice Sung, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

December 2, 2014

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 3, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimated)

December 8, 2014

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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