drugset / Trial / NCT04715958

SHAPE Neoadjuvant Chemotherapy Response

NCT04715958

Phase 2/3 Active not recruiting 122 enrolled Kibo Nam National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelDiagnostic

Summary

This phase II/III trial studies if contrast-enhanced ultrasounds using a contrast dye, perflutren lipid microspheres (Definity), can predict the response to chemotherapy by estimating the pressure in the cancer in patients with breast cancer that has spread to nearby tissues and lymph nodes (locally advanced). The efficacy of cancer therapy is affected by the pressure in the cancer. Definity is a contrast dye used to create better images during ultrasounds. The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.

Timeline

Start
2020-12-07
Primary completion
2026-10-31
Completion
2026-10-31

Drugs

EvaluationDrugModalityDoseRoute
Background Definity Diagnostic / imaging agent Intravenous

Indications