- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02174406
Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis
January 20, 2023 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1494
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
women scheduled for breast screening
Each patient will have the following:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 23, 2014
Primary Completion (Actual)
January 19, 2023
Study Completion (Actual)
January 19, 2023
Study Registration Dates
First Submitted
June 23, 2014
First Submitted That Met QC Criteria
June 23, 2014
First Posted (Estimate)
June 25, 2014
Study Record Updates
Last Update Posted (Actual)
January 23, 2023
Last Update Submitted That Met QC Criteria
January 20, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14-119
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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