Community Hospital Identification with MRI and Echocardiography in Detecting Chemotherapy-related Cardiotoxicity in Patients with Stage I-III Breast Cancer or Lymphoma

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

North Carolina

Charlotte
University of North Carolina-Charlotte
Status: Active
Contact: Yaorong Ge
Phone: 704-687-1951
Email: yge@uncc.edu
Lewisville
Albus Imaging LLC
Status: Active
Contact: Holly Goodwin
Phone: 336-776-0821
Email: holly@albusimaging.com
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: William Gregory Hundley
Phone: 336-716-0607
Email: ghundley@wakehealth.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

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.

OUTLINE:

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

Trial Phase

Phase II

Trial Type

Prevention

Lead Organization

Lead Organization
Wake Forest NCORP Research Base

Principal Investigator
William Gregory Hundley

Trial IDs

Primary ID 01115
Secondary IDs WF-01115, NCI-2015-01516, WF 01115
Clinicaltrials.gov ID NCT02566109