Community Hospital Identification with MRI and Echocardiography in Detecting Chemotherapy-related Cardiotoxicity in Patients with Stage I-III Breast Cancer or Lymphoma
- Newly diagnosed stage I-III breast cancer (including inflammatory and newly diagnosed recurrent breast cancer) or lymphoma with a > 2 year life expectancy
- Scheduled to receive chemotherapy with an Anthracycline (doxorubicin or epirubicin)
- Prior cancers allowed if no evidence of disease
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Enrollment in National Cancer Institute (NCI) protocol #: WF 98213; patients must receive fast MRI and 3D ECHO along with baseline (98213) MRI prior to first chemotherapy treatment
- Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
- Most breast tissue expanders are not allowed; (if uncertain, inform the MRI tech to confirm eligibility status)
- Unable to provide informed consent
- Symptomatic claustrophobia
- Pregnant or breasting feeding; a negative serum pregnancy test within 10 days prior to registration is required in patients with child-bearing potential; patients of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence (not having sex), oral contraceptives, intrauterine device (IUD), DeProvera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner); an acceptable, although less reliable method involves the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
I. To determine if baseline to 2-month measures of left ventricular (LV) volumes, T1/T2 times, and/or aortic pulse wave velocity (all acquired within 10 minutes) can predict baseline to 6-month post chemotherapy deteriorations in left ventricular ejection fraction (LVEF), as measured by a typical 45-min magnetic resonance imaging (MRI).
II. To compare the Albus 10-min MRI metrics with both echocardiography (ECHO) (including pulse wave velocity [PWV]) and cardiac serum biomarkers (TnI) for predicting baseline to 6 month deteriorations in LVEF.
III. To use exploratory algorithmic modeling to obtain optimal strategies for determining the combination of metrics (10-min MR, ECHO, serum biomarkers) at 2-months that predict the 6-month post chemotherapy deteriorations in cardiovascular (CV) function.
Patients scheduled for routine chemotherapy undergo a 10-minute fast MRI, a conventional 45-minute MRI, and a two dimensional (2D) and three dimensional (3D) echocardiogram prior to start of treatment.
Trial Phase Phase II
Trial Type Prevention
Wake Forest NCORP Research Base
William Gregory Hundley
- Primary ID 01115
- Secondary IDs NCI-2015-01516, WF-01115, WF-01115, WF 01115
- Clinicaltrials.gov ID NCT02566109