MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum

PRIMARY OBJECTIVES:

I. To design an automated MRI hardware/software platform for measuring and reporting left ventricular (LV) function (volumes, strain, and ejection fraction [EF]), T1 myocardial signal, and aortic pulse wave velocity (PWV).

II. To determine if pre- to 3 month post-anthracycline-based chemotherapy (Anth-bC) changes in our MRI platform generated measures of LV volumes, EF, strain, myocardial T1, and aortic PWV predict pre- to 24 month post-Anth-bC differences in these same parameters.

OUTLINE:

Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

Exercise Capacity Addendum Objectives:

Primary Objective:

• To provide critical participant enrollment data necessary to accomplish the R01 submission, including:
• Feasibility of screening, enrolling, and randomizing 21 Non or Hodgkin lymphoma and stage I-IV breast cancer patients including the reasons for failed randomization,
• Identification of barriers for participating in, or adhering to the Patient ES-AI and the Healthy Living Control Group.

Secondary Objective:

• In these 21 patients, at study initiation then 3 and 6 months after initiating Anth-bC or other potentially cardiotoxic cancer therapies, to assess the ability to ascertain: peak exercise cardiac output, calculated arteriovenous oxygen difference (A-V O2) and VO2 (maximum rate of oxygen), and pre-exercise measures of left ventricular and cognitive function, health-related quality of life, six-minute walk distance (6min WD) and fatigue. Ascertainment of the left ventricular function and health-related rate quality of life will be attempted in a manner similar to ascertainment of these variables from 47 individuals with lymphoma in the parent study.

PARENT STUDY:

Inclusion criteria

• Receiving >= 350 mg/m^2 of Anth-bC therapy, or a combination of Anth-bC (>= 250 mg/m^2) and subsequent paclitaxel or Herceptin
• Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

• Intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices, or other implanted electronic devices
• Ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal
• Allergy to gadolinium or other severe drug allergies
• Unstable angina
• Significant ventricular arrhythmias (> 20 premature ventricular contractions [PVCs]/minute due to gating difficulty)
• Acute myocardial infarction within 28 days
• Atrial fibrillation with uncontrolled ventricular response
• Moderate or severe aortic stenosis
• Claustrophobia
• Congestive heart failure (New York Heart Association [NYHA] class III or IV)
• Significant valvular disease, or significant pulmonary disease requiring supplemental oxygen therapy
• Participants unwilling to complete the protocol (24 month duration)
• Women who are pregnant
• Patients unable or unwilling to provide informed consent

EXERCISE CAPACITY ADDENDUM:

Inclusion criteria

• Men and women aged 18-85 with non- or Hodgkin lymphoma or I-IV stage breast cancer patients that expect to receive an anthracycline based chemotherapeutic regimen or other potentially cardiotoxic cancer therapies (e.g. chemotherapy regimens [anthracyclines, trastuzumab]), immuno-therapies (immune checkpoint inhibitors [ICI's]) or radiation (within 8 weeks of completion).
• Potential enrollees will need the capacity to walk at least two (2) city blocks on a flat surface.
• English speaking participants only will be enrolled.
• Stage IV breast cancer participants must have a 2 year survival prognosis and approval from their physician.

Exclusion criteria

The following are relative contraindications and can be considered by the medical director of the study:

• Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
• A recent history of alcohol or drug abuse.
• Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion.
• Other exclusions include those with contraindications to MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices.
• Unstable angina.
• Inability to exercise on a treadmill or stationary cycle.
• Significant ventricular arrhythmias (>20 PVCs/min due to gating difficulty).
• Atrial fibrillation with uncontrolled ventricular response.
• Acute myocardial infarction within 28 days.
• Moving within 12 months of enrollment.