[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05335811":3,"trial-entities:NCT05335811":86,"trial-summary:NCT05335811":92},{"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":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":35,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":42,"healthy_volunteers":14,"eligibility_criteria":43,"std_ages":55,"locations":58,"central_contacts":76,"overall_officials":79,"references":81,"see_also_links":82},"NCT05335811","2021-0784","First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging","RECRUITING","2028-08-31","2026-08","2026-08-20","2022-10-06","M.D. Anderson Cancer Center","OTHER",false,"18F-4FN represents a novel PET agent for imaging inflammation. Acute inflammatory signaling through the TLR axis recruits neutrophils and macrophages to inflammatory sites. Both cells activate the production of high energy reactive oxygen species\u002Freactive nitrogen species (RONS), setting off a cascade that can be leveraged to detect the presence of these inflammatory cells by molecular imaging. 18F-4FN is efficiently oxidized by high energy RONS, leading to retention and accumulation in human neutrophil-like cells in vitro, and at the sites of acute inflammation in vivo. Like 18F-FDG, 18F-4FN clears rapidly through the kidney at 1 hr following i.v. injection","OBJECTIVES:\n\nPrimary Objective:\n\nThe primary objective of this first-in-human (FIH) study is to determine the safety, biodistribution, and dosimetry profile of a novel positron emission tomography (PET) imaging tracer, 4-\\[18F\\]fluoro-1-naphthol (\\[18F\\]4FN), which specifically targets reactive oxygen species (ROS). A currently proposed indication for this radiopharmaceutical (RP) is to non-invasively quantify inflammation by PET\u002FCT imaging.\n\nExploratory Objectives:\n\nOne exploratory objective is to identify preliminary efficacy signals from PET\u002FCT images indicating that the new radiopharmaceutical localized to known or clinically-suspected tissues or regions of inflammation mediated by innate immune-related adverse events (irAE). Another exploratory objective is to determine if a time point other than one-hour post injection will yield clinically meaningful improvements to imaging data.",[18],"Endocrine Neoplasia",[],"INTERVENTIONAL","DIAGNOSTIC",[23],"PHASE1",{"count":25,"type":26},55,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","4-[18F]Fluoro-1-Naphthol","By vein (IV)",[30],[34],"[18F]4FN",[36],{"measure":37,"timeFrame":38},"To identify preliminary efficacy signals from PET images that correlate with clinical foci of ICI-related irAE.","through study completion, an average of 1 year",[],"ALL","18 Years",null,{"inclusion":44,"exclusion":48,"raw_text":54},[45,46,47],"Patient \\>\u002F= 18 years of age.","Patients with histologic diagnosis of solid or liquid tumor treated by ICI with evidence of or clinical suspicion of irAE or patients with suspected inflammation.","Normal range standard renal and liver function tests for age:",[49,50,51,52,53],"Pregnant or lactating women: pregnant women are excluded from this study because the effects of \\[18F\\]4FN in pregnancy are not known. Urine or serum pregnancy test (female \\\u003C\u002F= 60 years of age or childbearing potential) within 24 hours of the PET scan.","Subjects with contraindications to the use of \\[18F\\]4FN including confirmed allergy.","Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET\u002FCT scanner, because the hardware is not intended to support that weight.","Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the physician may significantly interfere with study compliance.","Children below the age of 18 are excluded because of the unknown but potential risk of administration of radiopharmaceuticals to minors.","Inclusion Criteria:\n\n* Patient \\>\u002F= 18 years of age.\n* Patients with histologic diagnosis of solid or liquid tumor treated by ICI with evidence of or clinical suspicion of irAE or patients with suspected inflammation.\n* Normal range standard renal and liver function tests for age:\n\neGFR \\>= 60 mL\u002Fmin\u002F1.73 m2\n\nAdequate liver function:\n\nBilirubin ≤ the upper limit of normal (ULN) Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ the ULN\n\nExclusion Criteria:\n\n* Pregnant or lactating women: pregnant women are excluded from this study because the effects of \\[18F\\]4FN in pregnancy are not known. Urine or serum pregnancy test (female \\\u003C\u002F= 60 years of age or childbearing potential) within 24 hours of the PET scan.\n* Subjects with contraindications to the use of \\[18F\\]4FN including confirmed allergy.\n* Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET\u002FCT scanner, because the hardware is not intended to support that weight.\n* Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the physician may significantly interfere with study compliance.\n* Children below the age of 18 are excluded because of the unknown but potential risk of administration of radiopharmaceuticals to minors.",[56,57],"ADULT","OLDER_ADULT",[59],{"facility":60,"status":7,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":73},"MD Anderson Cancer Center","Houston","Texas","77030","United States",[66,71],{"name":67,"role":68,"phone":69,"email":70},"Sanjit Tewari, MD","CONTACT","832-729-1874","sotewari@mdanderson.org",{"name":67,"role":72},"PRINCIPAL_INVESTIGATOR",{"lat":74,"lon":75},29.76328,-95.36327,[77],{"name":67,"role":68,"phone":78,"email":70},"(832) 729-1874",[80],{"name":67,"affiliation":12,"role":72},[],[83],{"label":84,"url":85},"M D Anderson Cancer Center","http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":87,"biomarkers":91},[88,89,90],"Endocrine Neoplasm","Hematologic Neoplasm","Solid Neoplasm",[],{"nct_id":4,"found":93,"summary":94,"prompt_version":104},true,{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is a first-in-human interventional study, meaning it's the first time this agent is being tested in people. It plans to enroll 55 participants.","completed","18F-Fluoro-1-Naphthol (18F-4FN) PET Imaging for Inflammation","This study is testing a new imaging agent called 4-[18F]Fluoro-1-Naphthol (18F-4FN) to see if it's safe and how it spreads in the body. This agent helps doctors see inflammation using a PET scan (a type of imaging that uses a special dye to show how your organs and tissues are working). The goal is to see if 18F-4FN can help identify inflammation, especially that caused by certain cancer treatments. You might be able to join if you are at least 18 years old, have a solid or liquid tumor, and are being treated with immunotherapy (ICI) with suspected inflammation, or have suspected inflammation. Your kidney and liver function must be normal. The study aims to enroll 55 participants, but its current recruitment status is unclear.","The primary endpoint, looking for preliminary efficacy signals, will be measured through study completion, which is an average of 1 year.",125,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]