Recruiting

3D Ultrasound

Sponsor:

Mayo Clinic

Code:

NCT04692818

Conditions

Breast Tumor

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GE Logiq E10 clinical ultrasound scanner

Verasonics research scanner

Study Details

Brief summary:

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

Conditions

Breast Tumor

Study ID

NCT04692818

Start date

Nov 10, 2021

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

125 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

GE Logiq E10 clinical ultrasound scanner

2D B-mode, Doppler, and shear wave elastography images of the lesion

Verasonics research scanner

3D B-mode imaging, microvessel imaging, and shear wave elastography

Primary outcome measure

  • BI-RADS Score [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Bobbie Ott

507-293-0922Ott.Bobbie@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Rica Pol

507-422-5118Pol.Hanarica@mayo.edu

Principal Investigator:

Shigao Chen, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 1, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-01.