Actively Recruiting
Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
Led by Katelyn Atkins · Updated on 2026-05-07
10
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to: 1. To deploy first-in-kind application of fluorine 18-sodium fluoride (18F-NaF) PET (Positron Emission Tomography) /MRI (Magnetic Resonance Imaging) imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure 2. To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and 3. To measure perturbations in the immune-modulatory and metabolic states following thoracic RT (Radiation Therapy) exposure in patients at high risk of cardiac dysfunction. Eligible patients will be adults (≥18 years old) with Stage II-III or oligo-metastatic stage IV malignancy (any histology) at high risk for RT-associated cardiac toxicity (defined as receiving ≥30 Gy (Gray) RT where the heart is in the treatment field54). The study will enroll a total of 10 subjects, recruited from Cedars-Sinai Medical Center. The primary endpoint will be successful completion of 18F-NaF PET imaging at the baseline and 6-month post-RT time points. Blood will be collected at baseline, end of RT, and 6-months post-RT.
CONDITIONS
Official Title
Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with clinical stage II-III or oligo-metastatic stage IV malignancy (any histology) planned for thoracic radiotherapy of 30 Gy or more with the heart in the radiation field
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Planned to receive standard of care radiotherapy treatment
- Able to provide written informed consent and comply with study requirements
- Able to read, write, and understand English
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) less than 45 mL/min/m2 or serum creatinine 1.5 mg/dL or higher
- Known or previous allergy to iodinated contrast, gadolinium contrast, or 18F-NaF tracer
- Unable to receive PET tracer
- Unable to receive MRI due to need for sedation, prohibitive implants, or ferromagnetic devices or foreign bodies
- Claustrophobia or inability to lie still or lie supine
- Pregnant or breastfeeding
- Unable to comply with visit instructions including holding breath or following procedure instructions
- Allergy to animal dander or animal-instigated asthma
- Any other condition that may make participation unsafe or unsuitable in the investigator's opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
C
Clinical Trial Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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