drugset / Trial / NCT02115607

Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

NCT02115607

NaSingle-groupOpen-labelDiagnostic

Summary

This is a diagnostic accuracy study to evaluate if two novel ultrasound (US) techniques, quantitative 3D subharmonic imaging (SHI) and Subharmonic Aided Pressure Estimation (SHAPE), used with an intravenous ultrasound contrast agent (Definity, Lantheus Medical Imaging, Billerica, MA), can track changes in locally advanced breast cancer (LABC) angiogenesis and interstitial fluid pressure (IFP), respectively, by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 60% (in part 1) or 30% (in part 2) of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment. Results will be compared to MRI and pathology.

Timeline

Start
2014-03
Primary completion
2018-05-23
Completion
2018-05-23

Drugs

EvaluationDrugModalityDoseRoute
Background Definity Diagnostic / imaging agent 3 ml Intravenous

Indications