PROactive Evaluation of Function to Avoid CardioToxicity

Breast Cancer Clinical Trial

— PROACT  

Official title:

PROactive Evaluation of Function to Avoid CardioToxicity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03862131
• Other study ID #: 201809177
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 13, 2019
• Est. completion date: July 7, 2024

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: July 7, 2024
• Est. primary completion date: July 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Cardiotoxicity
• Leukemia
• Lung Cancer
• Lymphoma
• Myeloma
• Sarcoma

Intervention

Device:
• MyoStrain®
MyoStrain® SENC software receives image data from MRI storage archives and performs viewing, image manipulation, communication, printing, and quantification of images.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Myocardial Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

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