3D Ultrasound Breast Imaging

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT04692818
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GE Logiq E10 clinical ultrasound scanner — DIAGNOSTIC_TEST
    2D B-mode, Doppler, and shear wave elastography images of the lesion
  • Verasonics research scanner — DIAGNOSTIC_TEST
    3D B-mode imaging, microvessel imaging, and shear wave elastography

Study Details

The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.

Key Dates

Start date
Nov 10, 2021
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
125 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Clinically indicated breast tumor biopsy
    Subjects with breast lesion and are scheduled for clinically-indicated biopsy will have 3D Multimodal Ultrasound Imaging performed

Primary Outcome Measure

BI-RADS Score [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Rica Pol
507-422-5118
Shigao Chen, PhD (PRINCIPAL_INVESTIGATOR)
Christine lee, MD, PhD (PRINCIPAL_INVESTIGATOR)

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