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Trial record 1 of 1 for:    PROactive Evaluation of Function to Avoid CardioToxicity (PROACT)
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PROactive Evaluation of Function to Avoid CardioToxicity (PROACT)

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ClinicalTrials.gov Identifier: NCT03862131
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Myocardial Solutions
Information provided by (Responsible Party):
Washington University School of Medicine

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 disease Intervention/treatment Phase
Cardiotoxicity Breast Cancer Lymphoma Sarcoma Leukemia Myeloma Lung Cancer Device: MyoStrain® Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 : March 13, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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




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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862131


Contacts
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Contact: Daniel J Lenihan, M.D., FACC 314-362-1291 djlenihan@wustl.edu
Contact: Kaitlin Moore, B.S. 314-273-0830 Kaitlin.m.moore@wustl.edu

Locations
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United States, Connecticut
Yale Not yet recruiting
New Haven, Connecticut, United States, 06520
Contact: Lauren Baldassarre, M.D., FACC, FSCMR, FSCCT         
Principal Investigator: Lauren Baldassarre, M.D., FACC, FSCMR, FSCCT         
United States, Indiana
Franciscan St. Francis Health Not yet recruiting
Indianapolis, Indiana, United States, 46237
Contact: Vijay Rao, M.D., Ph.D., FACC, FASE, FHFSA    317-893-1900      
Principal Investigator: Vijay Rao, M.D., Ph.D., FACC, FASE, FHFSA         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Daniel J Lenihan, M.D., FACC    314-362-1291    djlenihan@wustl.edu   
Contact: Kaitlin Moore, B.S.    314-273-0830    Kaitlin.m.moore@wustl.edu   
Principal Investigator: Daniel J Lenihan, M.D., FACC         
Sub-Investigator: Lindsay Peterson, M.D., MSCR         
Sub-Investigator: Brian Van Tine, M.D., Ph.D.         
Sub-Investigator: Neha Mehta-Shah, M.D.         
Sub-Investigator: Pamela Woodard, M.D.         
Sub-Investigator: Keith Stockerl-Goldstein, M.D.         
Sub-Investigator: Shahed Badiyan, M.D.         
Sub-Investigator: Clifford Robinson, M.D.         
United States, Texas
University of Texas Southwestern Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Vlad Zaha, M.D., Ph.D., FACC, FASE, FHFSA         
Principal Investigator: Vlad Zaha, M.D., Ph.D., FACC, FASE, FHFSA         
Sponsors and Collaborators
Washington University School of Medicine
Myocardial Solutions
Investigators
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Principal Investigator: Daniel J Lenihan, M.D., FACC Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03862131    
Other Study ID Numbers: 201809177
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries