Quantitative Cardiac Magnetic Resonance Imaging in Finding Heart Complications in Patients with Breast Cancer Receiving Chemotherapy

Status: Active

Description

This research trial studies quantitative cardiac magnetic resonance imaging in finding heart complications in patients with breast cancer receiving chemotherapy. One of the side effects in patients receiving chemotherapy is heart complications in which the heart muscle is weakened and no longer able to pump sufficient amounts of blood throughout the body, which can lead to shortness of breath, swollen ankles and feet, lack of energy, and a reduced capacity to carry out day-to-day activities. Identifying early signs of such heart complications using cardiac magnetic resonance may allow preventative treatment options to be made available in future.

Eligibility Criteria

Inclusion Criteria

  • Histologic diagnosis of breast carcinoma
  • Scheduled to receive standard clinical therapy designed by their treating oncologist
  • Patients should receive anthracycline as part of the recommended treatment
  • Able to give informed consent

Exclusion Criteria

  • Contraindication to contrast CMR including estimated glomerular filtration rate (eGFR) < 30 mls/min/1.73 m^2
  • Uncontrolled serious concurrent illness
  • Pregnancy or breast feeding

Locations & Contacts

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Contact: Reza Nezafat
Phone: 617-667-1747
Email: rnezafat@bidmc.harvard.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To quantify the distributions and temporal changes of cardiac magnetic resonance (CMR) parameters during chemotherapy.

II. To identify CMR predictors of cardiotoxicity in patients receiving anthracycline +/- neoadjuvant therapy.

III. Demonstrate the incremental predictive value of CMR versus (vs.) transthoracic echocardiogram (TTE) and serum biomarkers in cardiotoxicity.

OUTLINE:

Patients undergo CMR at baseline, after completion anthracycline treatment, immediately after completion of all treatments (patients may receive targeted HER2+ positive treatment or other treatments between 3rd and 4th scans), and 12 months after completion of treatment.

After completion of study treatment, patients are followed up in 1 and 2 year intervals.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Screening

Lead Organization

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Reza Nezafat

Trial IDs

Primary ID 15-017
Secondary IDs NCI-2016-00297
Clinicaltrials.gov ID NCT02666378