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.
Age ≥ 18 years.
Have clinical stage II-III or oligo-metastatic stage IV malignancy (any histology) planned to be treated with thoracic radiotherapy (≥30 Gy) where the heart is in the treatment field.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
Planning to receive standard of care radiotherapy treatment.
Estimated glomerular filtration rate (eGFR) <45 mL/min/m2 or serum creatinine ≥1.5 mg/dL.
Patients with a known or previous allergy to iodinated contrast, gadolinium contrast, and/or 18F-NaF tracer.
Inability to receive PET tracer.
Inability to receive MRI, requiring sedation for MRI, or prohibitive implant and/or device, including ferromagnetic implants and ferromagnetic foreign bodies.
Single group
18-F-NaF Cardiac PET/MRI and
Diagnostic testAll eligible subjects will receive 18-F-NaF Cardiac PET/MRI at baseline and 6 months after the completion of radiotherapy where the heart is in the treatment field
CT Angiogram
Diagnostic testAll eligible subjects will receive CT Angiogram at baselin
Feasibility of using F-NaF PET/MRI imaging
To determine the feasibility of using 18F-NaF PET/MRI imaging for detection of real-time atherosclerosis activity in patients at high risk of RT-associated cardiac dysfunction.
Incidence of MACE
To measure the one-year cumulative incidence of MACE (Major Adverse Cardiovascular Events). The one-year cumulative incidence of MACE will be estimated, adjusting for non cardiac death as a competing risk. For the secondary endpoint, one-year MACE cumulative incidence will be estimated using the Cumulative Incidence Function (CIF), while accounting for non-cardiac death as a competing risk.
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Katelyn Atkins
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
