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

Breast Cancer Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02310698
• Other study ID #: 14-240
• Status: Active, not recruiting
• Start date: December 2, 2014
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 487
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer Screening
• Breast Neoplasms

Intervention

Device:
• contrast enhanced digital mammography (CEDM)

• whole breast screening ultrasound (WBUS)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of cancers and false positive findings identified on a CEDM and WBUS as a measure of sensitivity and specificity.	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

External Links

•   Memorial Sloan Kettering Cancer Center