Clinical trial NCT03862131: PROactive Evaluation of Function to Avoid CardioToxicity
Official title: PROactive Evaluation of Function to Avoid CardioToxicity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cardiotoxicity
Breast Cancer
Lymphoma
Sarcoma
Leukemia
Myeloma
Lung Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Myocardial Solutions
First posted: 2019-03-05
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: 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
timeFrame: Through 36 months
measure: 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
timeFrame: Through 36 months
measure: 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
timeFrame: Through 36 months
measure: Ability of MyoStrain testing to detect subclinical cardiac dysfunction compared to standard cardiac imaging as measured by left ventricular ejection fraction
timeFrame: Through 36 months
measure: 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
timeFrame: Through 36 months
measure: Ability of MyoStrain testing to detect risk of developing cardiotoxicity compared to standard cardiac imaging as measured by left ventricular ejection fraction
timeFrame: Through 36 months
measure: 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
timeFrame: Through 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Joshua Mitchell, M.D., MSCI, FACC, FICOS
role: PRINCIPAL_INVESTIGATOR
References: