Using advanced imaging to detect heart damage from radiation in breast cancer patients
Single Institution Feasibility Study to Detect Radiation-Induced Cardiotoxicity in Receiving Thoracic Radiation Patients Using Hyperpolarized Carbon 13-Based Magnetic Resonance Spectroscopic Imaging
This study is testing if special MRI scans can help find early signs of heart damage in women with left-sided breast cancer who are receiving radiation therapy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04044872 on ClinicalTrials.gov |
What this trial studies
This study aims to identify early signs of radiation-induced cardiotoxicity in female patients with left-sided breast cancer undergoing standard radiation therapy. Participants will receive a baseline MRI scan with a special carbon-13 compound before treatment and a follow-up scan within three months after completing radiation. The focus is on assessing changes in mitochondrial metabolism as a potential marker for heart injury caused by radiation. By utilizing non-invasive imaging techniques, the study seeks to enhance understanding of cardiac risks associated with cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 100 with left-sided breast cancer who are scheduled to receive radiation therapy after surgery.
Not a fit: Patients with right-sided breast cancer or those not receiving radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and prevention strategies for heart damage in cancer patients receiving radiation therapy.
How similar studies have performed: While there is ongoing research into radiation-induced cardiotoxicity, this specific approach using hyperpolarized carbon-13 imaging is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Dallas, Texas
- Department of Radiation Oncology; UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Prasanna Alluri, MD, PhD — UTSW Radiation Oncology
- Study coordinator: Devin Holland, MS
- Email: devin.holland@utsouthwestern.edu
- Phone: 2146458052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.