Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Breast Carcinoma
Type
Interventional
Phase
Early Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 21 years and 125 years
Gender
Only males

Description

PRIMARY OBJECTIVE: I. To determine if the 3-dimensional (3D) subharmonic aided pressure estimation (SHAPE) results can be used to estimate interstitial fluid pressures (IFPs) in breast tumor and its surrounding tissue. SECONDARY OBJECTIVE: I. To determine if the malignancy of breast tumor can be pre...

PRIMARY OBJECTIVE: I. To determine if the 3-dimensional (3D) subharmonic aided pressure estimation (SHAPE) results can be used to estimate interstitial fluid pressures (IFPs) in breast tumor and its surrounding tissue. SECONDARY OBJECTIVE: I. To determine if the malignancy of breast tumor can be predicted by the 3D SHAPE results. OUTLINE: Patients undergo ultrasound without contrast. Patients then receive perflutren lipid microspheres (Definity) intravenously (IV) over 15 minutes and undergo CEUS.

Tracking Information

NCT #
NCT04721886
Collaborators
Not Provided
Investigators
Not Provided