Status:
TERMINATED
PROactive Evaluation of Function to Avoid CardioToxicity
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Myocardial Solutions
Conditions:
Cardiotoxicity
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 t...
Detailed Description
The primary purpose of the PROACT study is to test the accuracy of MyoStrain® to detect cardiotoxicity in patients on high risk cancer therapy. After undergoing baseline MRI and meeting eligibility cr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2024
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03862131
Start Date
March 13 2019
End Date
June 14 2024
Last Update
July 29 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110