Community Hospital Identification with MRI and Echocardiography in Detecting Chemotherapy-related Cardiotoxicity in Patients with Stage I-III Breast Cancer or Lymphoma
This phase II trial studies community hospital identification with magnetic resonance imaging (MRI) and echocardiography in detecting chemotherapy-related cardiotoxicity in patients with stage I-III breast cancer or lymphoma. Diagnostic procedures, such as MRI and echocardiography, may help find and diagnose chemotherapy-related toxicity in patients. Different ways of measuring heart health will be explored to determine if there are easier and faster ways to measure how chemotherapy may negatively impact the function and size of the heart when being treated for breast cancer or lymphoma at a community hospital.
- 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
Locations & Contacts
Contact: Yaorong Ge
Contact: Holly Goodwin
Contact: William Gregory Hundley
Trial Objectives and Outline
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 & Type
Wake Forest NCORP Research Base
William Gregory Hundley
Secondary IDs WF-01115, NCI-2015-01516, WF 01115
Clinicaltrials.gov ID NCT02566109