Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Locally Advanced Breast Carcinoma
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
Type
Interventional
Phase
Phase 2Phase 3
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 apply and evaluate a novel biomarker from 3-dimensional subharmonic aided pressure estimation (3D SHAPE) to predict neoadjuvant chemotherapy (NAC) response in patients with breast cancer. SECONDARY OBJECTIVE: I. To assess whether the accuracy of 3D SHAPE for predicting NAC r...

PRIMARY OBJECTIVE: I. To apply and evaluate a novel biomarker from 3-dimensional subharmonic aided pressure estimation (3D SHAPE) to predict neoadjuvant chemotherapy (NAC) response in patients with breast cancer. SECONDARY OBJECTIVE: I. To assess whether the accuracy of 3D SHAPE for predicting NAC response varies with breast cancer subtype. OUTLINE: Patients undergo contrast-enhanced ultrasound (CEUS) with Definity (perflutren lipid microspheres) intravenously (IV) over 10-15 minutes before NAC, after 10% (1-2 cycles) of NAC, and after 30% (2-4 cycles) of NAC. After completion of study, patients are followed up at the completion of NAC.

Tracking Information

NCT #
NCT04715958
Collaborators
Not Provided
Investigators
Not Provided