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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02174406
First received: June 23, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

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 Intervention
Breast Screening
Procedure: breast ultrasound
Procedure: DBT (Full field digital mammography + tomosynthesis)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • estimate the cancer detection rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 1500
Study Start Date: June 2014
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02174406

Contacts
Contact: Janice Sung, MD 646-888-5423
Contact: Christopher Comstock, MD 646-888-4500

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Janice Sung, MD    646-888-5423      
Contact: Christopher Comstock, MD    646-888-4500      
Principal Investigator: Janice Sung, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Janice Sung, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02174406     History of Changes
Other Study ID Numbers: 14-119
Study First Received: June 23, 2014
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 27, 2014