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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 9, 2014
Last verified: September 2014

June 23, 2014
September 9, 2014
June 2014
June 2016   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT02174406 on ClinicalTrials.gov Archive Site
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Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis
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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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

Breast Screening
  • Procedure: breast ultrasound
  • Procedure: DBT (Full field digital mammography + tomosynthesis)
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:
  • Procedure: breast ultrasound
  • Procedure: DBT (Full field digital mammography + tomosynthesis)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
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June 2016   (final data collection date for primary outcome measure)

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
Female
30 Years and older
No
Contact: Janice Sung, MD 646-888-5423
Contact: Christopher Comstock, MD 646-888-4500
United States
 
NCT02174406
14-119
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Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
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Principal Investigator: Janice Sung, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP