[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639991":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":40,"locations":46,"responsibleParty":88,"collaborators":90,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":103,"minAge":104,"maxAge":11,"enrollmentInfo":105,"targetDuration":11,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":119,"whyStopped":11,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"LVV Patients: [18F]LAFOV-PET\u002FCT & CT Angiogram","EXPERIMENTAL",null,[13,14],"Diagnostic Test: [18F]FDG Long-Axial Field of View (LAFOV)-PET\u002FCT","Diagnostic Test: CT Angiogram",{"label":16,"type":10,"description":11,"interventionNames":17},"Healthy Volunteers: [18F]LAFOV-PET\u002FCT & MR Angiogram",[13,18],"Diagnostic Test: MR Angiogram",[20,25,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DIAGNOSTIC_TEST","[18F]FDG Long-Axial Field of View (LAFOV)-PET\u002FCT","All participants will undergo an initial standard dose attenuation correction CT (ACCT) scan.\n\n\\[18F\\]FDG will be administered with a target injected dose of 1.5MBq\u002Fkg at 0 minutes in a single IV bolus.\n\nThe participants will undergo a dynamic LAFOV-PET\u002FCT scan between 0-55 minutes. This will be followed by a 10-minute cardiac-gated static PET\u002FCT scan performed between 60-70 minutes post-injection.\n\nA further ACCT (standard dose ACCT for LVV patients \\& low dose ACCT for healthy volunteers) followed by delayed static LAFOV-PET\u002FCT will subsequently be performed at +120 minutes post-injection for up to 10 minutes.",[16,9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"CT Angiogram","LVV patients will undergo a CT angiogram. This will take place immediately after their \\[18F\\]FDG LAFOV-PET\u002FCT.",[9],{"type":21,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"MR Angiogram","Healthy Volunteers will have an MR angiogram at Imperial College Healthcare NHS Trust. This scan visit will be performed on a separate date following the performance of their LAFOV-PET\u002FCT.",[16],[34,38],{"name":35,"affiliation":36,"role":37},"Tara D Barwick, MBChB MSc FRCR FRCP","Imperial College Healthcare NHS Trust","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":36,"role":37},"Taryn Youngstein, BSc MB BS MD (Res) MRCP",[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Laura J McLeavy - Clinical Trial Manager, MSc","CONTACT","0203 313 3720","laura.mcleavy13@imperial.ac.uk",[47,63,75],{"facility":48,"status":11,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Royal Free London NHS Foundation Trust","London","Greater London","NW3 2QG","United Kingdom","UK",{"type":55,"coordinates":56},"Point",[57,58],-0.12574,51.50853,{"lat":58,"lon":57},[61],{"name":62,"role":37,"phone":11,"phoneExt":11,"email":11},"Thomas Wagner, MBBS MSc FRCP",{"facility":64,"status":11,"city":49,"state":50,"zip":65,"country":52,"countryCode":53,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"King's College London","SE1 7EH",{"type":55,"coordinates":67},[57,58],{"lat":58,"lon":57},[70,73],{"name":71,"role":43,"phone":11,"phoneExt":11,"email":72},"Sheut-Ling Lam, PhD","sheut-ling.1.lam@kcl.ac.uk",{"name":74,"role":37,"phone":11,"phoneExt":11,"email":11},"Gary Cook, MBBS MSc MD FRCR FRCP",{"facility":36,"status":11,"city":49,"state":50,"zip":76,"country":52,"countryCode":53,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"W2 1NY",{"type":55,"coordinates":78},[57,58],{"lat":58,"lon":57},[81,84,86],{"name":82,"role":43,"phone":83,"phoneExt":11,"email":45},"Laura J McLeavy, BSc MSc","02033133720",{"name":85,"role":37,"phone":11,"phoneExt":11,"email":11},"Taryn Youngstein, BSc MB BS MD(Res) MRCP",{"name":87,"role":37,"phone":11,"phoneExt":11,"email":11},"Tara Barwick, MBChB MSc FRCR FRCP",{"type":89,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[91,92,94],{"name":64,"class":6},{"name":93,"class":6},"Royal Free Hospital NHS Foundation Trust",{"name":36,"class":6},"100639991","long-axial-field-of-view-lafov-18ffdg-petct-imaging-in-large-vessel-vasculitis-lvv-protocol-optimisation-study-100639991",false,"NCT07628075","Long-Axial Field of View (LAFOV) [18F]FDG PET\u002FCT Imaging in Large Vessel Vasculitis (LVV): Protocol Optimisation Study.","LAVA-FLOW","Inclusion Criteria LVV Patients:\n\n* ≥18 years of age\n* Newly diagnosed LVV (based on the 2022 American College of Rheumatology (ACR) and European Alliance of Associations for Rheumatology (EULAR) classification criteria or from a definite diagnosis of LVV on standard of care imaging)\n* WHO performance status 0-2\n* The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained\n* eGFR of ≥30 (mL\u002Fmin\u002F1.73m2) within 3 months of \\[18F\\]FDG injection in subjects who have a history of renal impairment, renal disease, renal transplant or diabetes\n\nExclusion Criteria LVV Patients:\n\n* The subject is pregnant or lactating\n* Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure\n* History of allergy to iodinated contrast\n* Commencement of steroids \\> 7 days prior to administration of the radiotracer\n* Poorly controlled diabetic with a blood glucose \\>11mmol\u002FL\n* Evidence of a significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial.\n\nInclusion Criteria Healthy Volunteers:\n\n* Three subjects ≥18 years of age that are also \\\u003C 50 years old and three subjects ≥50 years of age\n* WHO performance status 0-2\n* The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained\n\nExclusion Criteria Healthy Volunteers:\n\n* The subject is pregnant or lactating\n* Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure\n* Participants with any contra-indication to MRI\n* Known allergy to gadolinium-based contrast agents\n* History of smoking\n* History or current diagnosis of the following medical conditions:\n* Diabetes Mellitus\n* Chronic Kidney Disease\n* Atrial Fibrillation\n* Migraines\n* Rheumatoid Arthritis\n* Systemic Lupus Erythematosus (SLE)\n* Historic or current prescription of the following medications:\n* Any blood pressure medication\n* Any antipsychotic medication\n* Steroids\n* Weight of ≥75Kg (in order to keep the radiation dose \\\u003C10mSV for HV)\n* Evidence of any significant medical condition which, in the opinion of the Investigator, makes it undesirable for the HV to participate in the trial\n* Participants that have undergone any imaging investigation that exposes them to radiation within the previous 12 months",true,"ALL","18 Years",{"count":106,"type":107},18,"ESTIMATED","INTERVENTIONAL",[110],"NA","Large vessel vasculitis (LVV) is an autoimmune inflammatory disorder affecting the major arteries of the body. The diagnosis and monitoring this condition can be challenging, as patients often present with symptoms that are unclear, and the diagnostic criteria currently used are varied. Accurate diagnosis is essential because it helps to tailor the treatment to each patient. Some treatments, such as steroids and immunosuppressive medications, can have significant side effects, so they need to be used carefully and only when truly needed.\n\nAn \\[18F\\]FDG Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT) involves the injection of a small amount of radiolabelled sugar, which assesses glucose metabolism within the body. \\[18F\\]FDG PET\u002FCT is already used by the NHS to detect inflammation within the vessel walls and diagnose LVV. Current diagnostic criteria for LVV largely rely on visual assessment by a radiologist. This approach therefore has limitations and may not fully capture changes in the levels of inflammation over time.\n\nA new generation of scanners, known as Long Axial Field-of-View (LAFOV)-PET\u002FCT or Total Body PET, are currently transforming what is possible in the field of medical imaging. These LAFOV-PET\u002FCT scanners have new digital detectors that are more sensitive, produce sharper images, and can scan the entire body rapidly. This offers several potential advantages for patients with LVV, including the clearer detection of vessel wall inflammation, the ability to administer lower doses of the radiolabelled sugar (\\[18F\\]FDG), and the ability to take repeated pictures over time to measure subtle changes in blood flow and inflammation. Patients receiving a routine NHS \\[18F\\]FDG PET\u002FCT scan for LVV are typically scanned 60 minutes after injection of the radiotracer using a standard PET\u002FCT. Another benefit of LAFOV-PET\u002FCT scanners is their ability to assess the amount of the radiolabelled sugar taken up by the whole body almost as soon as it is injected which could give important additional information.\n\nAs part of the LAVA-FLOW study we are planning to combine LAFOV-PET\u002FCT with a CT Angiogram (CTA) in patients with LVV. A CTA is a scan that shows doctors what your blood vessels look like. It involves the injection of a dye into a vein that makes your blood vessels visible, highlighting vessel wall inflammation and vessel wall narrowing. This combination of LAFOV-PET\u002FCT and CTA therefore has the potential to give a much more detailed picture of LVV than is achievable using current methods.\n\nThe LAVA-FLOW study therefore aims to develop a standardised protocol to be used in different hospital centres across the UK for the imaging of LVV using LAFOV-PET\u002FCT. We also hope that the results of this particular study could lead to further larger studies with the potential to update the diagnostic criteria and improve the monitoring of this condition.",[113,114,115],"Large Vessel Vasculitis","Takayasu Arteritis","Giant Cell Arteritis (GCA)",[113,22,117,118],"Angiography","Protocol Optimisation","NOT_YET_RECRUITING","2026-06-01",{"date":122,"type":123},"2026-06-04","ACTUAL",{"date":125,"type":107},"2026-07-01",{"date":127,"type":107},"2028-01-01",{"name":5,"class":6},3]