Status:
SUSPENDED
Hyperpolarized Carbon 13-Based Metabolic Imaging to Detect Radiation-Induced Cardiotoxicity
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Thoracic Cancer
Left Sided Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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-induce...
Detailed Description
The global burden of cancer continues to rise with an incidence of 17.5 million cancer cases worldwide. Approximately 50% of all cancer patients receive radiation therapy as a component of their cance...
Eligibility Criteria
Inclusion
- 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:
- 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).
- 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)
- Ability to understand and the willingness to sign a written informed consent.
Exclusion
- Prior radiation involving the heart
- Subjects may not be receiving any known cardiotoxic agents for the 6 months prior to the study and during the study
- Diagnosis of connective tissue disorders, including systemic lupus erythematosis, scleroderma, or dermatomyositis
- Patients with stage IV cancer with life expectancy of less than 6 months
- 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
- eGFR \<30
- 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)
- History of psychiatric or addictive disorders that would preclude obtaining informed consent
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Key Trial Info
Start Date :
December 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04044872
Start Date
December 17 2019
End Date
December 1 2025
Last Update
September 5 2025
Active Locations (1)
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1
Department of Radiation Oncology; UT Southwestern Medical Center
Dallas, Texas, United States, 75390