Overview
The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to:
- 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
- To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and
- 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.
Eligibility
Inclusion Criteria
- 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.
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Ability to read, write, and understand English
Exclusion Criteria
- 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.
- Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.
- Subjects that are pregnant or breastfeeding.
- Subjects unable to comply with visit instructions, including inability to lie still, hold breathe, or follow procedure instructions.
- Allergy to animal dander or animal-instigated asthma.
- Any other condition which, in the opinion of the investigator, may make the patient a poor candidate for participation in a clinical trial