[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06014515":3,"trial-entities:NCT06014515":105,"trial-summary:NCT06014515":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":39,"secondary_outcomes":44,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":14,"eligibility_criteria":54,"std_ages":74,"locations":77,"central_contacts":96,"overall_officials":101,"references":103,"see_also_links":104},"NCT06014515","1921252","Single-tracer Multiparametric PET Imaging","RECRUITING","2033-08","2025-07","2026-03-10","2024-02-14","University of California, Davis","OTHER",true,"The overarching goal of this project is to develop and evaluate a single-tracer multiparametric positron emission tomography (PET) imaging solution for simultaneous imaging of blood flow and glucose metabolism using 18F-fluorodeoxyglucose (FDG) alone. The investigators working hypothesis is that quantitative blood flow can be extracted from dynamic 18F-FDG PET data by use of tracer kinetic modeling, in addition to glucose metabolism that 18F-FDG is conventionally used for.","Blood flow and glucose metabolism are two basic but vital physiological processes that are often dysregulated in major diseases. The phenomenon of flow-metabolism mismatch (or coupling) is of broad clinical and research significance. For example, (a) in ischemic cardiomyopathy, which affects several million people in the United States, myocardial flow-metabolism mismatch is clinically used for assessing tissue viability to select patients for surgical revascularization. Decreased blood flow but maintained glucose metabolism suggests the myocytes are still alive (while hibernating) and thus can benefit from revascularization; (b) In oncology, altered blood flow and glucose metabolism are closely related to two hallmarks of cancer - angiogenesis and increased cell metabolism. High metabolism-to-flow ratio may indicate cancer cells are resistant to therapy; (c) In the normal brain, cerebral blood flow and glucose metabolism are often coupled with each other but may become uncoupled in neurodegenerative diseases including Alzheimer's disease. There are critical interests and broad needs for integrated imaging of blood flow and metabolism in both clinical and research applications.",[18,19],"Healthy Subjects","Cardiovascular Disease",[21],"total body positron emission tomography","INTERVENTIONAL","BASIC_SCIENCE",[25],"EARLY_PHASE1",{"count":27,"type":28},60,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","18F-FDG","Each subject will undergo a dynamic 18F-FDG PET\u002FCT scan (this drug is FDA approved) and a dynamic 11C-butanol PET\u002FCT scan (this drug is under an IND) on the EXPLORER total-body PET\u002FCT system. The two scans will be performed on the same day or within a period of up to two weeks depending on subject, imaging agent and scanner availability.",[35],"Experimental: PET\u002FCT scans",{"type":31,"name":37,"description":33,"armGroupLabels":38},"11C-butanol",[35],[40],{"measure":41,"description":42,"timeFrame":43},"Blood Flow","The primary study endpoint is to evaluate if the blood flow estimated with 18F-FDG is quantitatively equal to the blood flow measured with the flow-dedicated tracer 11C-butanol measured in ml\u002Fmin\u002Fg.","during the procedure",[45,48],{"measure":46,"description":47,"timeFrame":43},"Metabolism change when using Butanol","The secondary endpoint is to assess the changes in metabolism between healthy subjects and patients using Butanol tracer measured in SUV",{"measure":49,"description":50,"timeFrame":43},"Metabolism change when using FDG","The secondary endpoint is to assess the changes in metabolism between healthy subjects and patients using FDG tracer measured in SUV","ALL","18 Years",null,{"inclusion":55,"exclusion":64,"raw_text":73},[56,57,58,59,60,61,62,63],"Adults (age ≥ 18 years old)","Ability to understand and willingness to sign an informed consent form","Ability to adhere to the study visit schedule and other protocol requirements.","Willing and able to fast for at least 6 hours before and for the duration of the scan","No strenuous exercise for 24 hours prior to being scanned","Willing to lie on the scanner bed for up to 60 minutes","Free of active COVID-19 symptoms","Patients with clinically acute or chronic conditions such as cardiovascular, cardiometabolic, or cardiopulmonary diseases, which may include but are not limited to ischemic heart disease, myocarditis, arrhythmias, heart failure, nonalcoholic fatty liver disease, COVID-related sequala, diabetes, hypertension, or renal disease that would result in changes in normal tissue perfusion and\u002For metabolism.",[65,66,67,68,69,70,71,72],"Self-reported history of dysphoria or anxiety in closed spaces","Body weight \\>240 kg due to limitations of the scanner bed","Pregnant or breast-feeding (due to risks of ionizing radiation; urine pregnancy test will be administered prior to start of each PET\u002FCT session for all participants between 18 to 60 years old who are able to get pregnant, unless documented hysterectomy or bilateral ovarian removal is available)","Blood glucose greater than 200 as assessed by fingerstick method before injection of 18F-FDG","Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only.","Prisoners","Any condition that would prevent the understanding or rendering of informed consent.","Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.","Inclusion Criteria:\n\n1. Inclusion Criteria for all research participants:\n\n   * Adults (age ≥ 18 years old)\n   * Ability to understand and willingness to sign an informed consent form\n   * Ability to adhere to the study visit schedule and other protocol requirements.\n   * Willing and able to fast for at least 6 hours before and for the duration of the scan\n   * No strenuous exercise for 24 hours prior to being scanned\n   * Willing to lie on the scanner bed for up to 60 minutes\n   * Free of active COVID-19 symptoms\n2. Inclusion Criteria for healthy volunteers only:\n\n   • Free of history of cardiovascular, inflammatory, infections or metabolic diseases that would result in changes in normal tissue perfusion and\u002For metabolism.\n3. Inclusion Criteria for patients with disease:\n\n   * Patients with clinically acute or chronic conditions such as cardiovascular, cardiometabolic, or cardiopulmonary diseases, which may include but are not limited to ischemic heart disease, myocarditis, arrhythmias, heart failure, nonalcoholic fatty liver disease, COVID-related sequala, diabetes, hypertension, or renal disease that would result in changes in normal tissue perfusion and\u002For metabolism.\n\nExclusion Criteria:\n\nParticipants are not eligible if they meet ANY of the following criteria:\n\n* Self-reported history of dysphoria or anxiety in closed spaces\n* Body weight \\>240 kg due to limitations of the scanner bed\n* Pregnant or breast-feeding (due to risks of ionizing radiation; urine pregnancy test will be administered prior to start of each PET\u002FCT session for all participants between 18 to 60 years old who are able to get pregnant, unless documented hysterectomy or bilateral ovarian removal is available)\n* Blood glucose greater than 200 as assessed by fingerstick method before injection of 18F-FDG\n* Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only.\n* Prisoners\n* Any condition that would prevent the understanding or rendering of informed consent.\n* Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"status":7,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":93},"UC Davis EXPLORER Molecular Imaging Center","Sacramento","California","95816","United States",[85,90],{"name":86,"role":87,"phone":88,"email":89},"Dana Little, MS","CONTACT","916-734-7749","dalittle@ucdavis.edu",{"name":91,"role":92},"Guobao Wang, PhD","PRINCIPAL_INVESTIGATOR",{"lat":94,"lon":95},38.58157,-121.4944,[97],{"name":98,"role":87,"phone":99,"email":100},"Clinical Research Team","916-731-9004","research-radiology-som@health.ucdavis.edu",[102],{"name":91,"affiliation":12,"role":92},[],[],{"nct_id":4,"conditions":106,"biomarkers":110},[107,108,109,18],"Cardiometabolic Disease","Cardiovascular Disorder","Cor Pulmonale",[],{"nct_id":4,"found":14,"summary":112,"prompt_version":122},{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study planning to enroll 60 participants. It involves receiving two different PET\u002FCT scans.","completed","Multiparametric PET Imaging for Blood Flow and Glucose Metabolism","This study aims to improve how we measure blood flow and glucose metabolism (how your body uses sugar for energy) at the same time using a single imaging technique called PET. Researchers are testing if they can get information about blood flow from a common PET drug called 18F-FDG, which is usually only used to measure glucose metabolism. You would receive two types of PET\u002FCT scans: one with 18F-FDG (an FDA-approved drug) and one with 11C-butanol (a drug still under investigation). This study is for healthy adults and those with cardiovascular disease, aged 18 and older. The goal is to see if 18F-FDG alone can provide both measurements, which could help doctors understand conditions like heart disease and cancer better. The current recruitment status is unclear.","Blood flow will be measured during the procedure.",126,"You would undergo two dynamic PET\u002FCT scans, either on the same day or within two weeks. You would also need to fast for at least 6 hours before the scan and avoid strenuous exercise for 24 hours prior.","Not stated in the trial record.",[32,37],"v2"]