Trial results for the PROactive Evaluation of Function to Avoid CardioToxicity (MyoStrain®) study were posted on ClinicalTrials.gov on 2025-07-29. The study, which enrolled 49 participants, investigated the ability of MyoStrain® to detect myocardial dysfunction during cancer treatment, reporting a peak ROC AUC of 0.876.
Background
Cardiotoxicity is a significant concern for patients undergoing treatment for various cancers, including breast cancer. Certain cancer therapeutics can lead to cardiac dysfunction, necessitating careful monitoring to mitigate long-term heart damage. Early detection of cardiotoxicity is crucial for managing patient health and potentially adjusting treatment plans. This study aimed to evaluate an intramyocardial strain analysis package, MyoStrain®, used with cardiac MRI, as a tool for early detection and management of this treatment-related complication.
Trial design
This Phase 2 study, which was terminated, enrolled 49 participants. The trial focused on conditions including Cardiotoxicity, Breast Cancer, Lymphoma, Sarcoma, and Leukemia. The intervention evaluated was an intramyocardial strain analysis package with cardiac MRI (MyoStrain®), intended to assist in the early detection and management of cardiotoxicity from cancer therapeutics. The study did not list specific primary outcomes. Key measurements were collected across a MyoStrain® Unblinded Treatment Arm and a MyoStrain® Blinded Control Arm, as well as a combined arm.
Key results
The trial reported several measurements for the ROC AUC (Receiver Operating Characteristic Area Under the Curve) of MyoStrain® compared to standard CMR measurements (LV End Diastolic Volume Index, LV End Systolic Volume Index, LV Stroke Volume Index and Left Ventricular Ejection Fraction) to detect myocardial dysfunction during cancer treatment:
- For the MyoStrain® Unblinded Treatment Arm, an ROC AUC of 0.876 (probability) was observed.
- For the MyoStrain® Blinded Control Arm, an ROC AUC of 0.853 (probability) was observed.
- For the Combined MyoStrain® Control Arm and Treatment Arm, an ROC AUC of 0.864 (probability) was observed.
- Another measurement for the MyoStrain® Unblinded Treatment Arm showed an ROC AUC of 0.603 (probability).
- Another measurement for the MyoStrain® Blinded Control Arm showed an ROC AUC of 0.790 (probability).
- Another measurement for the Combined MyoStrain® Control Arm and Treatment Arm showed an ROC AUC of 0.679 (probability).
- A further measurement for the MyoStrain® Unblinded Treatment Arm showed an ROC AUC of 0.522 (probability).
- A further measurement for the MyoStrain® Blinded Control Arm showed an ROC AUC of 0.532 (probability).
- A further measurement for the Combined MyoStrain® Control Arm and Treatment Arm showed an ROC AUC of 0.515 (probability).
- Yet another measurement for the MyoStrain® Unblinded Treatment Arm showed an ROC AUC of 0.501 (probability).
- Yet another measurement for the MyoStrain® Blinded Control Arm showed an ROC AUC of 0.689 (probability).
- And for the Combined MyoStrain® Control Arm and Treatment Arm, an ROC AUC of 0.589 (probability) was observed.
What this means
The posted results provide data on the diagnostic accuracy of MyoStrain® in detecting myocardial dysfunction in cancer patients at risk of cardiotoxicity. The reported ROC AUC values, ranging from 0.501 to 0.876, suggest varying levels of performance for the intramyocardial strain analysis package in different contexts or measurement iterations within the study arms. While the trial was terminated, these measurements contribute to the understanding of MyoStrain®'s potential in identifying cardiac issues during cancer treatment, which is particularly relevant for patients with conditions like breast cancer who often receive cardiotoxic therapies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03862131, titled "PROactive Evaluation of Function to Avoid CardioToxicity", were posted on 2025-07-29 on clinicaltrials.gov.