This study investigates how common it is for patients with stage I-III breast cancer or lymphoma to have fibrosis (scarring) of the heart before they receive treatment with anthracyclines and/or trastuzumab, if patients develop any heart dysfunction or damage (cardiotoxicity) after receiving cancer treatment, and compare the information collected from before and after the treatment to see if there is any association between fibrosis (scarring) of the heart before treatment with anthracyclines and/or trastuzumab and subsequent heart dysfunction or damage. Information from this study may help researchers better understand the relationship between cardiac fibrosis and cardiotoxicity with cancer-related treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02798679.
PRIMARY OBJECTIVES:
I. Determine the prevalence and predictors of cardiac fibrosis in cancer patients before treatment with anthracyclines/trastuzumab.
II. Determine the association between pre-existing cardiac fibrosis and cumulative incidence of cardiotoxicity at 24 months from initiation of anthracyclines/trastuzumab.
III. Determine the association between pre-existing cardiac fibrosis and cardiac troponin levels after initiation of anthracyclines/trastuzumab.
OUTLINE:
Patients undergo cardiac magnetic resonance imaging (MRI) over 1 hour at baseline and 24 months, and undergo collection of blood samples at baseline, 3 months, and 24 months. Patients also complete questionnaires at baseline, and 3, 6, 12, and 24 months.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorChetan N. Shenoy
