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Recruiting NCT04692818

3D Ultrasound Breast Imaging

No phase Interventional Breast Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GE Logiq E10 clinical ultrasound scanner, Verasonics research scanner.
Who it may be relevant to
Registry conditions: Breast Tumor. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

3D Multimodal Ultrasound Imaging for Breast Cancer

Overview

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

Interventions

  • Diagnostic test GE Logiq E10 clinical ultrasound scanner
    2D B-mode, Doppler, and shear wave elastography images of the lesion
  • Diagnostic test Verasonics research scanner
    3D B-mode imaging, microvessel imaging, and shear wave elastography

Primary outcome measures

  • BI-RADS Score [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT04692818 · 20-010751 · W81XWH-21-1-0063

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗