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

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ClinicalTrials.gov Identifier: NCT02174406
Recruitment Status : Active, not recruiting
First Posted : June 25, 2014
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Breast Screening Procedure: breast ultrasound Procedure: DBT (Full field digital mammography + tomosynthesis)

Study Type : Observational
Estimated Enrollment : 1494 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis
Actual Study Start Date : June 23, 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
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.
Procedure: breast ultrasound
Procedure: DBT (Full field digital mammography + tomosynthesis)



Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174406


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Janice Sung, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02174406     History of Changes
Other Study ID Numbers: 14-119
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
Ultrasound
Digital Breast Tomosynthesis
14-119