This phase I trial evaluates the effects of chemotherapy (doxorubicin) on the metabolism of pyruvate in cardiac mitochondria in patients with breast cancer. This trial looks to develop a new non-invasive magnetic resonance imaging method, that may be useful for early detection of heart damage, which is a known side effect of the anticancer chemotherapy drug (doxorubicin). Magnetic resonance imaging is a method to take pictures or measure metabolism of the inside of the body. Pyruvate, when metabolized in the body, helps researchers can see how it is used by the heart, which may help them understand the effects of doxorubicin on the heart. Information from this study may help to better understand the effect of chemotherapy on the heart.
Additional locations may be listed on ClinicalTrials.gov for NCT03685175.
Locations matching your search criteria
United States
Texas
Dallas
UT Southwestern/Simmons Cancer Center-DallasStatus: Active
Contact: Vlad G Zaha
Phone: 214-645-2727
FEASIBILITY OBJECTIVE:
I. To determine feasibility and proof of concept initial patients (n=10) will be studied post cardiotoxic therapy and again 1 to 6 months after the first scan following medical therapy (SOC).
PRIMARY OBJECTIVE:
I. To test the hypothesis that doxorubicin-induced cardiotoxicity is associated with a signature of early impaired aerobic cardiac metabolism through pyruvate dehydrogenase from baseline to post doxorubicin treatment.
SECONDARY OBJECTIVES:
I. To determine the correlation between pre and post cardiotoxic therapy between myocardial strain, shown to have prognostic value for anthracycline induced cardiotoxicity, and myocardial [1-13C]lactate/[13C]bicarbonate ratio.
II. Establish repeatability of measurements of [1-13C]lactate/[13C]bicarbonate ratio and [5-13C]glutamate signal in a series of healthy volunteers.
III. Test the hypothesis that cardiotoxicity due to radiation therapy involving the heart field is associated with a signature of early impaired aerobic cardiac metabolism through pyruvate dehydrogenase.
IV. Test the hypothesis that cardiotoxicity due to medical anticancer therapy and radiation therapy involving the heart field is associated with a signature of early impaired aerobic cardiac metabolism through pyruvate dehydrogenase.
V. Test the hypothesis that cardiotoxicity due to novel medical anticancer therapy (e.g. human epidermal growth factor receptor 2 [HER2] blockade) is associated with a signature of early impaired aerobic cardiac metabolism through pyruvate dehydrogenase.
VI. Test the hypothesis that a persistent decrease in left ventricular ejection fraction (LVEF) below 50% due to cardiotoxic therapies is associated with a progressive signature of impaired aerobic cardiac metabolism through pyruvate dehydrogenase.
EXPLORATORY OBJECTIVE:
I. To explore the association between potential risk factors for anthracycline-induced cardiotoxicity and myocardial [1-13C]lactate/[13C]bicarbonate ratio and [5-13C]glutamate signal.
OUTLINE: Patients are assigned to 1 of 2 studies.
STUDY I (FEASIBILITY STUDY): Patients undergo a cardiac magnetic resonance imaging (MRI) over 1 hour and receive two injections of hyperpolarized carbon C 13 pyruvate intravenously (IV) after completion of standard of care cardiotoxic therapy and 1-6 months after completing standard of care cardiotoxic therapy.
STUDY II (FORMAL STUDY): Patients undergo a cardiac MRI over 1 hour and receive two injections of hyperpolarized carbon C 13 pyruvate IV at baseline before administration of standard of care cardiotoxic therapy and after completion of standard of care cardiotoxic therapy.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorVlad G Zaha
