TerminatedEarly Phase 1

Hyperpolarized Carbon 13-Based Metabolic Imaging to Detect Radiation-Induced Cardiotoxicity

Stopped: It has been terminated due to investigator decision to no longer pursue grant funding to support the study.

United States3 participantsStarted 2019-12-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Benign or malignant tumor of the breast (left-sided only) or thorax
✓. Stage I to IV. If stage IV, patient must have life expectancy equal to or greater than 6 months
✓. ECOG performance status 0-1
✓. The patient must be deemed an appropriate candidate for standard of care radiation therapy
✓. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
✓.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
✓.2. A female of postmenopausal status is defined as patients over 60 or greater OR patients age 50-59 who meet the following criteria:
✓. Ability to understand and the willingness to sign a written informed consent.

Exclusion criteria

What they're measuring

To determine if radiation-induced cardiac injury causes myocardial mitochondrial dysfunction

Timeframe: at 1 month before the radiation

Trial details

NCT IDNCT04044872

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-30

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