Hyperpolarized Carbon 13-Based Metabolic Imaging to Detect Radiation-Induced Cardiotoxicity
NCT04044872 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2026-02-02
Summary
Patients enrolled in the study will receive standard of care adjuvant or definitive breast, chest wall or thoracic radiation therapy.Cardiac mitochondrial dysfunction is a hallmark of radiation-induced cardiac injury. Reactive oxygen species (ROS) produced by ionizing radiation cause oxidation of mitochondrial proteins and alter oxidative phosphorylation and pyruvate metabolism(5). The goal of this study is to detect early changes in the mitochondrial metabolism in situ as a marker for subclinical radiation-induced cardiotoxicity.
Conditions
- Thoracic Cancer
- Left Sided Breast Cancer
Interventions
- DIAGNOSTIC_TEST
-
[1-13C]pyruvate along with MRI imaging
\[1-13C\]pyruvate: 0.1 mmol/kg dose will be injected at 5 mL/s followed by a 25 mL saline flush at 5 mL/s at the time of imaging performed at baseline (prior to radiation therapy), and 1 month after completion of radiation therapy.
Sponsors & Collaborators
-
University of Texas Southwestern Medical Center
lead OTHER
Principal Investigators
-
Prasanna Alluri, MD, PhD · UTSW Radiation Oncology
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-17
- Primary Completion
- 2021-08-30
- Completion
- 2021-08-30
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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