Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis
1 other identifier
observational
1,494
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2014
CompletedStudy Start
First participant enrolled
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2023
CompletedJanuary 23, 2023
January 1, 2023
8.6 years
June 23, 2014
January 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
women scheduled for breast screening
Each patient will have the following: * Screening whole breast ultrasound * DBT (Full field digital mammography + tomosynthesis views in the CC and MLO projections). The only change in patient management will be the addition of digital breast tomosynthesis views in patients scheduled for FFDM alone. DBT is currently clinically approved and being offered on a voluntary basis to patients scheduled for FFDM.
Interventions
Eligibility Criteria
All women scheduled for a WBUS and a FFDM on the same day or within the following 30 days of each other will be identified by the investigators/research staff at MSKCC clinic.
You may qualify if:
- Any women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Janice Sung, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2014
First Posted
June 25, 2014
Study Start
June 23, 2014
Primary Completion
January 19, 2023
Study Completion
January 19, 2023
Last Updated
January 23, 2023
Record last verified: 2023-01