NCT03862131

PROactive Evaluation of Function to Avoid CardioToxicity

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to evaluate the ability of an intramyocardial strain analysis package with cardiac MRI to assist in the early detection and management of cardiotoxicity from therapeutics used to treat cancer.

Detailed description

The primary purpose of the PROACT study is to test the accuracy of MyoStrain® to detect cardiotoxicity in patients on high risk cancer therapy. After undergoing baseline MRI and meeting eligibility criteria, patients will be further randomized to an unblinded arm (MyoStrain® measured and available to the treatment team) and a blinded arm (MyoStrain® measured but not available to the treatment team). This randomization will aid in an exploratory aim of testing the feasibility of MyoStrain® to guide cardioprotective therapy in the unblinded vs blinded arms. However, as all patients will have MyoStrain® measured, all patients (both treatment arms) will be combined for testing the primary outcome measure.

Conditions

• Cardiotoxicity
• Breast Cancer
• Lymphoma
• Sarcoma
• Leukemia
• Myeloma
• Lung Cancer

Interventions

Type	Name	Description
DEVICE	MyoStrain®	MyoStrain® SENC software receives image data from MRI storage archives and performs viewing, image manipulation, communication, printing, and quantification of images.

Timeline

• Start date: 2019-03-13
• Primary completion: 2024-06-14
• Completion: 2024-06-14
• First posted: 2019-03-05
• Last updated: 2025-07-29
• Results posted: 2025-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study