3D Ultrasound Microvessel Imaging for Breast Masses

Mayo Clinic

Status and phase

Completed

Early Phase 1

Conditions

Breast Carcinoma

Treatments

Procedure: Ultrasound Microvessel Imaging

Other: Electronic Health Record Review

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04925817

NCI-2021-04853 (Registry Identifier)

P30CA015083 (U.S. NIH Grant/Contract)

R03CA241020 (U.S. NIH Grant/Contract)

21-002713 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.