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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

487 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-02

Study Completion Date

2025-03-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT

NCT02643966

Breast Cancer

COMPLETED NA

Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography

NCT00535327

Breast Cancer

COMPLETED

Breast Ultrasound and Mammography in Screening Women at High Risk for Breast Cancer

NCT00072501

Breast Cancer

COMPLETED NA

Automated Breast Ultrasound Screening

NCT02650778

Breast Cancer

COMPLETED

Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy

NCT00535184

Breast Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Screening

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

contrast enhanced digital mammography (CEDM)

Intervention Type DEVICE

whole breast screening ultrasound (WBUS)

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

contrast enhanced digital mammography (CEDM)

Intervention Type DEVICE

whole breast screening ultrasound (WBUS)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No