Clinical trial · Interventional
Hyperpolarized Carbon 13-Based Metabolic Imaging to Detect Radiation-Induced Cardiotoxicity
Single Institution Feasibility Study to Detect Radiation-Induced Cardiotoxicity in Receiving Thoracic Radiation Patients Using Hyperpolarized Carbon 13-Based Magnetic Resonance Spectroscopic Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): It has been terminated due to investigator decision to no longer pursue grant funding to support the study.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Left Sided Breast Cancer | — | UNRESOLVED | — |
| Thoracic Cancer | Malignant Thoracic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [1-13C]pyruvate along with MRI imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm:Diagnosing Cardiotoxicity when on Radiation therapy
- interventionNames
- Diagnostic Test: [1-13C]pyruvate along with MRI imaging
Primary outcomes (1)
- measure
- To determine if radiation-induced cardiac injury causes myocardial mitochondrial dysfunction
- timeFrame
- at 1 month before the radiation
- description
- To determine if radiation-induced cardiac injury causes myocardial mitochondrial dysfunction as measured by increase in \[1-13C\]lactate/ \[13C\]bicarbonate ratio and a decrease in \[5-13C\]glutamate formation in patients receiving radiotherapy to the thorax
Secondary outcomes (1)
- measure
- Determination of the prognostic value decreased of myocardial mitochondrial pyruvate flux in predicting clinically significant radiation induced cardiotoxicity.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Benign or malignant tumor of the breast (left-sided only) or thorax 2. Stage I to IV. If stage IV, patient must have life expectancy equal to or greater than 6 months 3. ECOG performance status 0-1 4. The patient must be deemed an appropriate candidate for standard of care radiation therapy 5. 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. 5.1 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: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 5.2. A female of postmenopausal status is defined as patients over 60 or greater OR patients age 50-59 who meet the following criteria: * s/p bilateral oophorectomy, OR * with intact uterus without menses in the past 12 months OR, * with biochemical confirmation of post-menopausal status (estradiol in the menopausal range based on local laboratory criteria) 6. Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: 1. Prior radiation involving the heart 2. Subjects may not be receiving any known cardiotoxic agents for the 6 months prior to the study and during the study 3. Diagnosis of connective tissue disorders, including systemic lupus erythematosis, scleroderma, or dermatomyositis 4. Patients with stage IV cancer with life expectancy of less than 6 months 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements 6. eGFR \<30 7. Any contraindication to MRI (including, but not limited to metal implants and devices contraindicated at 3T, breast tissue expanders, non-MR compatible IV port, claustrophobia) 8. History of psychiatric or addictive disorders that would preclude obtaining informed consent 9. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
References
Publications (0)
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