Breast Tumor
Conditions
Brief summary
The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.
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
Sponsors
Mayo Clinic
United States Department of Defense
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BI-RADS Score | Baseline | 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. |
Countries
United States
Contacts
CONTACTBobbie Ott
PRINCIPAL_INVESTIGATORShigao Chen, PhD
Mayo Clinic
PRINCIPAL_INVESTIGATORChristine Lee, MD, PhD
Mayo Clinic in Rochester
Outcome results
None listed