PROactive Evaluation of Function to Avoid CardioToxicity

PROactive Evaluation of Function to Avoid CardioToxicity

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.

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.

Inclusion Criteria:

• Participant in the SURVIVE registry
• Signed informed consent form for PROACT
• Histological diagnosis of any cancer type (patients with treated and clinically stable brain metastasis are acceptable)
• Scheduled to receive anti-cancer therapy (radiation therapy is permitted)

Exclusion Criteria:

• Contraindication to magnetic resonance imaging (MRI)
• Unable to comply with study investigations (in the judgment of the investigator)
• Life expectancy less than 1 year
• Note: If a patient develops a temporary contraindication (e.g. temporary tissue expanders in breast cancer patients) after the baseline MRI, follow up MRIs will be discontinued for safety for the duration in which the patient has the contraindication. However, once the patient is no longer contraindicated to receiving MRIs, the study schedule may resume with their next scheduled MRI time point from the date of enrollment. Therefore, some time points may be skipped during the patient's enrollment in the study.

Also, if a patient needs a repeat MRI at any time point for any reason (i.e. panic attack during the MRI causing them to not be able to continue, unreadable images, etc.), we may repeat the MRI as long as the patient is willing.