PROACT: PROactive Evaluation of Function to Avoid CardioToxicity

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT03862131
Collaborator
Myocardial Solutions (Industry)
55
Enrollment
4
Locations
2
Arms
49.6
Anticipated Duration (Months)
13.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: MyoStrain®
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Masking Description:
Patients will be classified based on baseline segmental MyoStrain Fast-SENC strain testing, into lower and higher risk groups. The higher risk group will be randomized with half blinded and half unblinded to intramyocardial strain in terms of assessing cardiotoxicity incidence and management. Physicians will have knowledge of MyoStrain intramyocardial strain and cardiac MRI information in the unblinded group to augment standard of care in detecting and managing cardiotoxicity. Physicians will not have access to or knowledge of intramyocardial strain and cardiac MRI data, except 4 standard cardiac measures, for patients in the blinded group.
Primary Purpose:
Supportive Care
Official Title:
PROactive Evaluation of Function to Avoid CardioToxicity
Actual Study Start Date :
Mar 13, 2019
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

ArmIntervention/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
  • Outcome Measures

    Primary Outcome Measures

    1. 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 [6 months]

      -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

    2. 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 [6 months]

      -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

    3. 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 [6 months]

      -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

    4. Ability of MyoStrain testing to detect subclinical cardiac dysfunction compared to standard cardiac imaging as measured by left ventricular ejection fraction [6 months]

      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

    5. 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 [6 months]

      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

    6. Ability of MyoStrain testing to detect risk of developing cardiotoxicity compared to standard cardiac imaging as measured by left ventricular ejection fraction [6 months]

      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

    7. 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 [6 months]

      -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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1YaleNew HavenConnecticutUnited States06520
    2Franciscan St. Francis HealthIndianapolisIndianaUnited States46237
    3Washington University School of MedicineSaint LouisMissouriUnited States63110
    4University of Texas SouthwesternDallasTexasUnited States75390

    Sponsors and Collaborators

    • Washington University School of Medicine
    • Myocardial Solutions

    Investigators

    • Principal Investigator: Joshua Mitchell, M.D., MSCI, FACC, FICOS, Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT03862131
    Other Study ID Numbers:
    • 201809177
    First Posted:
    Mar 5, 2019
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 2, 2021