3D Ultrasound Breast Imaging

ConditionBreast Tumor

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorMayo Clinic

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

< 18 years of age.

Lacking capacity to consent

Pregnant or lactating

Receiving cancer therapy such as chemotherapy or radiation therapy

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

125 Participants

are divided into 1 treatment group

Group A: Clinically indicated breast tumor biopsyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov

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