PROactive Evaluation of Function to Avoid CardioToxicity (PROACT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sarcoma; Lymphoma; Leukemia; Breast Cancer; Lung Cancer; Cardiotoxicity; Myeloma
• Intervention / Treatment: Device: MyoStrain®

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MyoStrain® unblinded treatment arm; After consenting to the PROACT study, patients will undergo a baseline MRI to determine their risk stratification for the study. This baseline MyoStrain® MRI must demonstrate 2 or more segments measuring >-10% or 9 or more segments >-17% for entrance into the study as the Higher Risk Group; The unblinded treatment arm will enhance patient management by augmenting standard of care with serial MyoStrain® monitoring of the impact of cancer therapy on myocardial function.; Higher Risk unblinded patients will continue to undergo MyoStrain® MRI testing, regardless of study arm, at 1 month (+1 week), 3 months (+ 1 week), 6 months (+1 week), 12 months (+ 30 days), 24 months (+30 days), and 36 months (+30 days) after the baseline visit.; In addition to the MyoStrain® testing, patients will also be asked to complete a brief patient satisfaction questionnaire at each PROACT time point.	Device: MyoStrain®; MyoStrain® SENC software receives image data from MRI storage archives and performs viewing, image manipulation, communication, printing, and quantification of images.; Other Names: Cardiac MRI Imaging Software; Intramyocardial Strain
Active Comparator: MyoStrain® blinded control arm; After consenting to the PROACT study, patients will undergo a baseline MRI to determine their risk stratification for the study. This baseline MyoStrain® MRI must demonstrate 2 or more segments measuring >-10% or 9 or more segments >-17% for entrance into the study as the Higher Risk group; The blinded control arm will provide investigators with LVEF and LVEDV/LVESV measurements, which are clinical, in conjunction with standard of care; Higher Risk blinded patients will continue to undergo MyoStrain® MRI testing, regardless of study arm, at 1 month (+1 week), 3 months (+ 1 week), 6 months (+1 week), 12 months (+ 30 days), 24 months (+30 days), and 36 months (+30 days) after the baseline visit.; In addition to the MyoStrain® testing, patients will also be asked to complete a brief patient satisfaction questionnaire at each PROACT time point.	Device: MyoStrain®; MyoStrain® SENC software receives image data from MRI storage archives and performs viewing, image manipulation, communication, printing, and quantification of images.; Other Names: Cardiac MRI Imaging Software; Intramyocardial Strain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and accuracy of detection of patients with myocardial dysfunction who necessitate cardioprotection during cancer treatment using MyoStrain compared to standard of care (SOC) as measured by left ventricular ejection fraction	-Receiver operating characteristic curves will be used to identify criteria for standard of care and MyoStrain cardiac features to detect subclinical cardiotoxicity. -. Considering many patients will have a complex management of cardioactive medications as well as cancer treatment regimen, the classification of cardiotoxicity status will be based on a clinical committee to designate whether the patient experienced no cardiotoxicity, functional decline without cardiotoxicity, subclinical cardiotoxicity, or clinical cardiac dysfunction at each exam time point	Through 36 months
Sensitivity & accuracy of detection of patients requiring cardioprotection therapy for cardiotoxicity during cancer treatment who demonstrate an improvement in myocardial function using MyoStrain compared to SOC as measured by LVEF	-Receiver operating characteristic curves will be used to identify criteria for standard of care and MyoStrain cardiac features to detect improvement in cardiac function due to cardioprotective therapy in patients exhibiting cardiotoxicity -. Considering many patients will have a complex management of cardioactive medications as well as cancer treatment regimen, the classification of cardiotoxicity status will be based on a clinical committee to designate whether the patient experienced no cardiotoxicity, functional decline without cardiotoxicity, subclinical cardiotoxicity, or clinical cardiac dysfunction at each exam time point	Through 36 months
Sensitivity and accuracy of detection of patients at risk of developing cardiotoxicity using MyoStrain compared to standard of care as measured by left ventricular ejection fraction	-Receiver operating characteristic curves will be used to identify criteria for standard of care and MyoStrain cardiac features to predict risk of developing cardiotoxicity. -. Considering many patients will have a complex management of cardioactive medications as well as cancer treatment regimen, the classification of cardiotoxicity status will be based on a clinical committee to designate whether the patient experienced no cardiotoxicity, functional decline without cardiotoxicity, subclinical cardiotoxicity, or clinical cardiac dysfunction at each exam time point	Through 36 months
Ability of MyoStrain testing to detect subclinical cardiac dysfunction compared to standard cardiac imaging as measured by left ventricular ejection fraction	Multivariate regression and logistic regression will be used with "stepwise" option to identify significant predictors for standard of care and MyoStrain cardiac features for predicting cardiotoxicity. Furthermore, the investigators will use decision trees for identifying the importance of MyoStrain cardiac features in cardiotoxicity risk prediction based on standard assessment of variables	Through 36 months
Impact of MyoStrain imaging on medical management of cardiotoxicity through early detection of at risk patients compared to standard cardiac imaging as measured by left ventricular ejection fraction	Multivariate regression and logistic regression will be used with "stepwise" option to identify significant predictors at standard of care and MyoStrain cardiac features for detecting improvement in cardiac function due to cardioprotective therapy in patients exhibiting cardiotoxicity. Furthermore, the investigators will use decision trees for identifying the importance of MyoStrain cardiac features in cardioprotection risk prediction based on standard assessment of variables	Through 36 months
Ability of MyoStrain testing to detect risk of developing cardiotoxicity compared to standard cardiac imaging as measured by left ventricular ejection fraction	Multivariate regression and logistic regression will be used with "stepwise" option to identify significant predictors at standard of care and MyoStrain cardiac features for predicting risk of developing cardiotoxicity. Furthermore, the investigators will use decision trees for identifying the importance of MyoStrain segmental intramyocardial strain in cardiotoxicity risk prediction based on standard assessment of variables	Through 36 months
Sensitivity and accuracy of detection of patients with myocardial dysfunction who necessitate cardioprotection during cancer treatment using MyoStrain compared to standard of care (SOC) as measured by stroke (LVSV) volumes indexed to body surface area	Receiver operating characteristic curves will be used to identify criteria for standard of care and MyoStrain cardiac features to detect subclinical cardiotoxicity. -. Considering many patients will have a complex management of cardioactive medications as well as cancer treatment regimen, the classification of cardiotoxicity status will be based on a clinical committee to designate whether the patient experienced no cardiotoxicity, functional decline without cardiotoxicity, subclinical cardiotoxicity, or clinical cardiac dysfunction at each exam time point	Through 36 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Myocardial Solutions
• Investigators: Principal Investigator: Joshua Mitchell, M.D., MSCI, FACC, FICOS, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Estimated): July 7, 2024
• Study Completion (Estimated): July 7, 2024

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Cardiotoxicity
• Other Study ID Numbers: 201809177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes