[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05041166":3,"trial-entities:NCT05041166":78,"trial-summary:NCT05041166":81},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":58,"locations":61,"central_contacts":69,"overall_officials":70,"references":74,"see_also_links":75},"NCT05041166","21-309","A Study of [13C]Pyruvate as an Imaging Agent for Magnetic Resonance Imaging in Healthy Volunteers","Optimized In-Human [13C]Pyruvate MRI For Assessment Of Physiologic Reference Data In Different Organs","ENROLLING_BY_INVITATION","2026-09","2026-02","2026-02-20","2021-09-01","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of the study is to learn about the use of \\[13C\\]pyruvate as an imaging agent for MRI scans. In past studies, researchers have seen that \\[13C\\]pyruvate can improve imaging with MRI scans. However, they would like to know more about how the imaging agent is distributed in healthy organs and tissues. This study will provide additional information about the use of \\[13C\\]pyruvate as an imaging agent for MRI scans, and it will show us how the substance is metabolized (changed into energy) in the organs and tissues of healthy volunteers. For (n=5) volunteers undergoing brain imaging we will compare the standard injection at 5mL\u002Fsecond with a slower infusion (0.1-1mL\u002Fsecond) to achieve a 60 second infusion time, to approach quasi steady-state metabolism and improve SNR.",[18],"Healthy Volunteers",[20,21,5],"MRI","Hyperpolarized (HP) [13C] pyruvate","INTERVENTIONAL","DIAGNOSTIC",[25],"PHASE1",{"count":27,"type":28},50,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Hyperpolarized [13C] Pyruvate","Will be injected at a dosage of 0.43 ± 0.05 mL\u002Fkg body weight",[35,36],"Protocol optimization cohort","Tissue reference cohort",[38],{"measure":39,"description":40,"timeFrame":41},"Signal-to-noise ratios","will be used to assess image quality, and to compare the different technical setups. The setup providing the highest SNR will be considered optimal.","1 day",[],"ALL","18 Years","80 Years",true,{"inclusion":48,"exclusion":51,"raw_text":57},[49,50],"Age between 18-80","Negative serum or urine pregnancy test for female volunteers of childbearing age and potential (as defined by MSKCC Standards \\& Guidelines), from assays obtained \\\u003C2 weeks prior to study enrollment. Urine pregnancy tests are only valid for the day of test.",[52,53,54,55,56],"Breast-feeding","History of metabolic (e.g. diabetes) and renal functional disorders.","Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)","Acute major illness (e.g., unstable cardiovascular condition, systemic malignant diseases, etc.).","Standard MRI safety screening will be applied (MRI screening questionnaire); volunteers with MR unsafe devices, or conditional devices where research mode is not allowed, will be excluded.","Inclusion Criteria:\n\nFifty healthy volunteers will be included.\n\n* Age between 18-80\n* Negative serum or urine pregnancy test for female volunteers of childbearing age and potential (as defined by MSKCC Standards \\& Guidelines), from assays obtained \\\u003C2 weeks prior to study enrollment. Urine pregnancy tests are only valid for the day of test.\n\nExclusion Criteria:\n\n* Breast-feeding\n* History of metabolic (e.g. diabetes) and renal functional disorders.\n* Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)\n* Acute major illness (e.g., unstable cardiovascular condition, systemic malignant diseases, etc.).\n* Standard MRI safety screening will be applied (MRI screening questionnaire); volunteers with MR unsafe devices, or conditional devices where research mode is not allowed, will be excluded.",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":13,"city":63,"state":63,"zip":64,"country":65,"geoPoint":66},"New York","10065","United States",{"lat":67,"lon":68},40.71427,-74.00597,[],[71],{"name":72,"affiliation":13,"role":73},"Vesselin Miloushev, MD","PRINCIPAL_INVESTIGATOR",[],[76],{"label":13,"url":77},"http:\u002F\u002Fwww.mskcc.org\u002Fmskcc\u002Fhtml\u002F44.cfm",{"nct_id":4,"conditions":79,"biomarkers":80},[18],[],{"nct_id":4,"found":82,"summary":15,"prompt_version":15},false]