[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544792":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":72,"collaborators":21,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":21,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":21,"enrollmentInfo":85,"targetDuration":21,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":39,"whyStopped":21,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Cedars-Sinai Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm","EXPERIMENTAL","Fluorine-18-sodium fluoride (18F-NaF) PET\u002FMRI imaging with CT angiography",[13,14],"Diagnostic Test: 18-F-NaF Cardiac PET\u002FMRI and","Diagnostic Test: CT Angiogram",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DIAGNOSTIC_TEST","18-F-NaF Cardiac PET\u002FMRI and","All eligible subjects will receive 18-F-NaF Cardiac PET\u002FMRI at baseline and 6 months after the completion of radiotherapy where the heart is in the treatment field",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"CT Angiogram","All eligible subjects will receive CT Angiogram at baselin",[9],[27],{"name":28,"affiliation":5,"role":29},"Katelyn Atkins, MD, PhD","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":21,"email":35},"Clinical Trial Navigator","CONTACT","3104232133","GroupCancerTrialInformation@cshs.org",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Cedars Sinai Medical Center","RECRUITING","Los Angeles","California","90048","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-118.24368,34.05223,{"lat":49,"lon":48},[52,54,55,58,60,62,64,66,68,70],{"name":53,"role":33,"phone":34,"phoneExt":21,"email":35},"Clinical Trial Recruitment Navigator",{"name":28,"role":29,"phone":21,"phoneExt":21,"email":21},{"name":56,"role":57,"phone":21,"phoneExt":21,"email":21},"Alan Kwan, MD, MS","SUB_INVESTIGATOR",{"name":59,"role":57,"phone":21,"phoneExt":21,"email":21},"Louise Thomson, MD",{"name":61,"role":57,"phone":21,"phoneExt":21,"email":21},"Andriana Nikolova, MD, PhD",{"name":63,"role":57,"phone":21,"phoneExt":21,"email":21},"Anja Karlstaedt, MD, Phd",{"name":65,"role":57,"phone":21,"phoneExt":21,"email":21},"Eric Vail, MD",{"name":67,"role":57,"phone":21,"phoneExt":21,"email":21},"Celeste Eno, PhD",{"name":69,"role":57,"phone":21,"phoneExt":21,"email":21},"Stephen Shiao, MD, PhD",{"name":71,"role":57,"phone":21,"phoneExt":21,"email":21},"Elizabeth McKenzie, PhD",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"SPONSOR_INVESTIGATOR","Katelyn Atkins","Sponsor-Investigator","100544792","early-phase-1-real-time-atherosclerosis-activity-after-thoracic-radiotherapy-using-sodium-fluoride-positron-emission-tomography-100544792",false,"NCT06373497","Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography","IT2023-08-ATKINS-ATHERO-RT: Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography","Inclusion Criteria\n\n* Age ≥ 18 years.\n* 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.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.\n* Planning to receive standard of care radiotherapy treatment.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n* Ability to read, write, and understand English\n\nExclusion Criteria\n\n* Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002Fm2 or serum creatinine ≥1.5 mg\u002FdL.\n* Patients with a known or previous allergy to iodinated contrast, gadolinium contrast, and\u002For 18F-NaF tracer.\n* Inability to receive PET tracer.\n* Inability to receive MRI, requiring sedation for MRI, or prohibitive implant and\u002For device, including ferromagnetic implants and ferromagnetic foreign bodies.\n* Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.\n* Subjects that are pregnant or breastfeeding.\n* Subjects unable to comply with visit instructions, including inability to lie still, hold breathe, or follow procedure instructions.\n* Allergy to animal dander or animal-instigated asthma.\n* Any other condition which, in the opinion of the investigator, may make the patient a poor candidate for participation in a clinical trial","ALL","18 Years",{"count":86,"type":87},10,"ESTIMATED","INTERVENTIONAL",[90],"EARLY_PHASE1","The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to:\n\n1. To deploy first-in-kind application of fluorine 18-sodium fluoride (18F-NaF) PET (Positron Emission Tomography) \u002FMRI (Magnetic Resonance Imaging) imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure\n2. To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and\n3. To measure perturbations in the immune-modulatory and metabolic states following thoracic RT (Radiation Therapy) exposure in patients at high risk of cardiac dysfunction.\n\nEligible 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.",[93],"Oligometastatic Disease",[95,96,97,98,99,100],"Thoracic Radiotherapy","PET Imaging","MRI Imaging","18 F-NaF","Clinical Stage II","Clinical Stage III","2026-05-01",{"date":103,"type":104},"2026-05-07","ACTUAL",{"date":106,"type":104},"2025-06-19",{"date":108,"type":87},"2026-10",{"name":74,"class":6},1]