3D Ultrasound Microvessel Imaging for Breast Masses

This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.

Inclusion Criteria

Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy.
Lesion size of 3 mm or larger.
Age 18 or greater.

Exclusion Criteria

Women with previous breast surgery or breast implant.
Lacking the capacity to consent.
Women who are pregnant or lactating.
Women who are receiving cancer therapy such as chemotherapy or radiation therapy.

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04925817.

PRIMARY OBJECTIVES:

I. Optimization of imaging protocol for this new ultrasound technology.

II. Investigate the diagnostic performance of the new ultrasound technology using clinically indicated biopsy as the reference standard.

OUTLINE:

Patients undergo 3 dimensional (D) ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.

Trial PhasePhase O

Trial Typediagnostic

Lead OrganizationMayo Clinic in Rochester

Principal InvestigatorShigao D. Chen

Primary ID21-002713
Secondary IDsNCI-2021-04853
ClinicalTrials.gov IDNCT04925817

3D Ultrasound Microvessel Imaging for Breast Masses

Inclusion Criteria

Exclusion Criteria

Have a question?
We're here to help

Which trials are right for you?

3D Ultrasound Microvessel Imaging for Breast Masses

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

Have a question?We're here to help

Which trials are right for you?

Have a question?
We're here to help