3D Ultrasound Breast Imaging

NCT ID: NCT04692818

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-10

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Clinically indicated breast tumor biopsy

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

Group Type EXPERIMENTAL

GE Logiq E10 clinical ultrasound scanner

Intervention Type DIAGNOSTIC_TEST

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

Verasonics research scanner

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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GE Logiq E10 clinical ultrasound scanner

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

Intervention Type DIAGNOSTIC_TEST

Verasonics research scanner

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shigao Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Christine Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bobbie Ott

Role: CONTACT

507-293-0922

Facility Contacts

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Rica Pol

Role: primary

507-422-5118

Related Links

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Other Identifiers

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W81XWH-21-1-0063

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20-010751

Identifier Type: -

Identifier Source: org_study_id