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NCT02174406 Clinical Trial

Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis

Breast Screening Clinical Trial

Official title:
Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02174406
Other study ID # 14-119
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 23, 2014
Est. completion date January 19, 2023

Study information
Verified date January 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and DBT.

Recruitment information / eligibility
Status Completed
Enrollment 1494
Est. completion date January 19, 2023
Est. primary completion date January 19, 2023
Accepts healthy volunteers No
Gender Female
Age group 30 Years and older
Eligibility Inclusion Criteria: - Any women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other. Exclusion Criteria: - Age < 30 years old - Male patients - Patients with any clinical symptoms (palpable mass, nipple discharge, etc) - Patients with known cancer - Patients with any breast surgery or biopsy within 90 days prior to the study - Patients with breast implants - Patients pregnant or lactating

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• breast ultrasound

• DBT (Full field digital mammography + tomosynthesis)

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 estimate the cancer detection rates The detection rate of each imaging test is defined as the proportion of patients who are positive on that imaging test who truly have the disease compared to the total number of women screened. A positive imaging test is defined as a test with a recommendation for biopsy (BI-RADS 4 or 5). 2 years
See also
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Active, not recruiting NCT04761055 - Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer N/A
Completed NCT03846947 - Novel MRI Sequence MR Fingerprinting in Breast MRI Feasibility Study N/A
Terminated NCT03929822 - Can Contrast-Enhanced Spectral Mammography Improve the Accuracy of a Diagnosis

External Links