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PROactive Evaluation of Function to Avoid CardioToxicity (PROACT)

Primary Purpose

Cardiotoxicity, Breast Cancer, Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MyoStrain®
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiotoxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MyoStrain® unblinded treatment arm

MyoStrain® blinded control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
March 1, 2019
Last Updated
March 2, 2023
Sponsor
Washington University School of Medicine
Collaborators
Myocardial Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT03862131
Brief Title
PROactive Evaluation of Function to Avoid CardioToxicity
Acronym
PROACT
Official Title
PROactive Evaluation of Function to Avoid CardioToxicity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient funding/staff
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
March 2, 2023 (Actual)
Study Completion Date
March 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Myocardial Solutions

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiotoxicity, Breast Cancer, Lymphoma, Sarcoma, Leukemia, Myeloma, Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MyoStrain® unblinded treatment arm
Arm Type
Experimental
Arm Description
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.
Arm Title
MyoStrain® blinded control arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MyoStrain®
Other Intervention Name(s)
Cardiac MRI Imaging Software, Intramyocardial Strain
Intervention Description
MyoStrain® SENC software receives image data from MRI storage archives and performs viewing, image manipulation, communication, printing, and quantification of images.
Primary Outcome Measure Information:
Title
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
Description
-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
Time Frame
Through 36 months
Title
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
Description
-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
Time Frame
Through 36 months
Title
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
Description
-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
Time Frame
Through 36 months
Title
Ability of MyoStrain testing to detect subclinical cardiac dysfunction compared to standard cardiac imaging as measured by left ventricular ejection fraction
Description
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
Time Frame
Through 36 months
Title
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
Description
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
Time Frame
Through 36 months
Title
Ability of MyoStrain testing to detect risk of developing cardiotoxicity compared to standard cardiac imaging as measured by left ventricular ejection fraction
Description
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
Time Frame
Through 36 months
Title
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
Description
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
Time Frame
Through 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Mitchell, M.D., MSCI, FACC, FICOS
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

PROactive Evaluation of Function to Avoid CardioToxicity

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