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RecruitingInterventional
3D Multimodal Ultrasound Imaging for Breast Cancer
NCT ID: NCT04692818Sponsor: Mayo ClinicLast updated: 2026-06-01
Summary
The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.
Arms & interventions
- Diagnostic TestGE Logiq E10 clinical ultrasound scanner
2D B-mode, Doppler, and shear wave elastography images of the lesion
- Diagnostic TestVerasonics research scanner
3D B-mode imaging, microvessel imaging, and shear wave elastography
Outcome measures
Primary
BI-RADS Score
BI-RADS scores will be obtained using 2D B-mode ultrasound images from the GE Logiq E10 clinical scanner, and using 3D B-mode images from the Verasonics scanner. A 7-point BI-RADS scale will be used, with a score of 1, 2, or 3 considered negative and 4a, 4b, 4c, and 5 considered positive.
Time frame: Baseline
Eligibility criteria
Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria:
* Adult women ≥ 18 years of age.
* solid breast lesion and ultrasound guided biopsy (either as part of their clinical care or through participation in other IRB-approved studies)
* lesion size of 3mm or larger
Exclusion Criteria:
* \< 18 years of age.
* Lacking capacity to consent
* Pregnant or lactating
* Receiving cancer therapy such as chemotherapy or radiation therapy
Study locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Shigao Chen, PhD · Principal Investigator
Christine lee, MD, PhD · Principal Investigator