protocolSection identificationModule nctId: NCT06373497, orgStudyIdInfo id: IIT2023-08-ATKINS-ATHERO-RT, briefTitle: Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Katelyn Atkins, class: OTHER, descriptionModule briefSummary: 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 exposure2. To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and3. 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., conditionsModule conditions: Oligometastatic Disease, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: 18-F-NaF Cardiac PET/MRI and, interventions name: CT Angiogram, outcomesModule primaryOutcomes measure: Feasibility of using F-NaF PET/MRI imaging, secondaryOutcomes measure: To measure changes in standard uptake value (SUV), secondaryOutcomes measure: To measure changes in coronary microcalcification activity (CMA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cedars Sinai Medical Center, city: Los Angeles, state: California, zip: 90048, country: United States, contacts name: Clinical Trial Recruitment Navigator, role: CONTACT, phone: 310-423-2133, email: cancer.trial.info@cshs.org, contacts name: Katelyn Atkins, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alan Kwan, MD, MS, role: SUB_INVESTIGATOR, contacts name: Louise Thomson, MD, role: SUB_INVESTIGATOR, contacts name: Andriana Nikolova, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Anja Karlstaedt, MD, Phd, role: SUB_INVESTIGATOR, contacts name: Eric Vail, MD, role: SUB_INVESTIGATOR, contacts name: Celeste Eno, PhD, role: SUB_INVESTIGATOR, contacts name: Stephen Shiao, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Elizabeth McKenzie, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False