NCT04925817

3D Ultrasound Microvessel Imaging for Breast Masses

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Electronic Health Record Review	Medical record reviewed
PROCEDURE	Ultrasound Microvessel Imaging	Undergo 3D ultrasound microvessel imaging

Timeline

• Start date: 2021-08-19
• Primary completion: 2023-05-18
• Completion: 2023-05-18
• First posted: 2021-06-14
• Last updated: 2024-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study