Effect of Cardiotoxic Anticancer Chemotherapy on the Metabolism of [1-13C]Pyruvate in Cardiac Mitochondria
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 100
Summary
- Conditions
- Breast Neoplasms
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a prospective, single-center study in women and men with breast cancer requiring doxorubicin treatment. The study will be conducted in parallel to the standard clinical care, at dedicated visits. In this study patients will undergo a cardiac magnetic resonance (MR) signal detection after inj...
This is a prospective, single-center study in women and men with breast cancer requiring doxorubicin treatment. The study will be conducted in parallel to the standard clinical care, at dedicated visits. In this study patients will undergo a cardiac magnetic resonance (MR) signal detection after injection of hyperpolarized carbon-13 pyruvate. The study will be performed before the course of doxorubicin, and after completing doxorubicin treatment. Patients will be screened prior to enrollment based on study specific inclusion and exclusion criteria and MRI safety criteria. On the day of the metabolic cardiac MR scan an IV line will be inserted and the participant will receive a bolus of oral glucose. The ingestion of glucose will be required to prepare the state of the heart for metabolic imaging. Following this preparation the participant will undergo a cardiac MR study of about 45 minutes, including carbon-13 dedicated sequences. A separate dedicated cardiac MRI session may be completed in certain participants. In part I 10 patients will be studied after completion of doxorubicin therapy for correlation with cardiac mechanical function. In part II up to 100 patients will be studied before and after completion of doxorubicin therapy for identification of subclinical cardiac metabolic changes.
Tracking Information
- NCT #
- NCT03685175
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Vlad G Zaha, MD, PhD Advanced Imaging Research Center