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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast 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

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

Treatment and study plan

Breast ultrasound

Procedure

DBT (Full field digital mammography + tomosynthesis)

Procedure

Primary outcomes

estimate the cancer detection rates

Time frame: 2 years

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).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2023
Study completion: 2023
First posted: Jun 25, 2014
Registry last updated: Jan 23, 2023

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.

Published trials that share one or more normalized conditions with this study.

Completed