[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07704333":3,"trial-entities:NCT07704333":110,"trial-summary:NCT07704333":123},{"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":17,"conditions":18,"keywords":25,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":37,"interventions":40,"primary_outcomes":48,"secondary_outcomes":53,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":77,"locations":80,"central_contacts":97,"overall_officials":102,"references":105,"see_also_links":106},"NCT07704333","10002488","Assessment of [18F]-Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy Volunteers and Subjects With Invasive Mold Infections","Phase 1 Clinical Trial for The Assessment Of [18F]-Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy Volunteers and Subjects With Invasive Mold Infections","RECRUITING","2029-06-30","2026-07-08","2026-07-17","2026-07-09","National Institutes of Health Clinical Center (CC)","NIH",null,"Background:\n\nFungal infections can cause serious disease in the lungs and other parts of the body. About 3.8 million people die with fungal infections each year. Currently, there is no way to find fungal infections in the body using imaging scans. Researchers want to see if a new tracer (a radioactive drug that collects in certain body tissues) can help find fungal infections using positron emission tomography (PET)\u002Fcomputed tomography (CT) scans.\n\nObjective:\n\nTo test a new tracer (\\[18F\\]Fluorocellobiose) for PET\u002FCT scans in people with and without fungal infections.\n\nEligibility:\n\nPeople aged 18 years and older who have fungal infections. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 3 clinic visits.\n\nThe first visit will be for screening. Participants will have a physical exam with blood tests and a test of their heart function.\n\nThe second visit will be for PET\u002FCT scanning. A thin tube called a catheter will be inserted into a vein in the arm. The study tracer will be given through the catheter. For the scans, participants will lie on a padded bed that slides through a donut-shaped machine. The machine will take pictures of the inside of the body from the head to the upper thighs. Some participants will have only 1 scan; others will have 2 scans. The second scan will be about 90 minutes after the first one.\n\nThe third visit will be for repeat blood and urine tests.","Study Description:\n\nThis study is intended to assess the pharmacokinetics (distribution, metabolism and excretion) of the novel PET radiopharmaceutical \\[18F\\]FCB in healthy individuals and to evaluate whether radioactive signal accumulation will be seen in individuals with certain fungal infection after \\[18F\\]FCB injection\n\nObjectives:\n\nPrimary:\n\n-To evaluate uptake of \\[18F\\]FCB in subjects with invasive fungal infections\n\nSecondary:\n\n* To study the pharmacokinetics and radiation dosimetry of \\[18F\\]FCB in healthy volunteers\n* To establish the safety of \\[18F\\]FCB in healthy volunteers and in subjects with mold infections\n\nEndpoints:\n\nPrimary:\n\n-Standardized uptake values (SUV) values from the site of suspected fungal infection after injection of \\[18F\\]FCB\n\nSecondary:\n\n-SUV values from various organs after injection of \\[18F\\]FCB, Organ time-activity curves (from dynamic data 1-60 minutes after injection), Radiation dose to organs of the body, Safety evaluation tests",[19,20,21,22,23,24],"Aspergillos","Mucormye","Dimorphic","Other Molds","Non-Aspergillos","Non-Mucormycosis",[26,27,28,29,30,31,32],"Phase 1","[18F]-Fluorocellobiose ([18F]FCB)","Pharmacokinetics","Healthy Volunteers","Invasive Mold Infections","Standard uptake value","Target\u002Fnon-target ratio","INTERVENTIONAL","BASIC_SCIENCE",[36],"PHASE1",{"count":38,"type":39},100,"ESTIMATED",[41],{"type":42,"name":27,"description":43,"armGroupLabels":44},"DRUG","PET tracer spcific for fungal infections.",[45,46,47],"Healthy Volunteer (Group 1)","Healthy Volunteers (Group 2)","Infected Subjects (Group 3-4)",[49],{"measure":50,"description":51,"timeFrame":52},"SUV values from the site of suspected mold infection after injection of [18F]FCB.","To evaluate uptake of \\[18F\\]FCB in subjects with mold infections","3 years",[54,57,60,62],{"measure":55,"description":56,"timeFrame":52},"SUV values and time activity curves (TACs) from various organs for the duration of the scan after injection of [18F]FCB","To study the pharmacokinetics and dosimetry of \\[18F\\]FCB in healthy volunteers.",{"measure":58,"description":59,"timeFrame":52},"Medical evaluation, clinical safety laboratory tests and EKG","To establish the safety of \\[18F\\]FCB in healthy volunteers and in subjects with different Fungal infections",{"measure":61,"description":56,"timeFrame":52},"Organ time-activity curves (from dynamic data)",{"measure":63,"description":56,"timeFrame":52},"Radiation burden to organs of the body","ALL","18 Years","100 Years",true,{"inclusion":69,"exclusion":75,"raw_text":76},[70,71,72,73,74],"Partner vasectomy (making sterile)","Bilateral tubal ligation","Intrauterine devices (IUDs)","Hormonal implants (such as Implanon)","Other hormonal methods (birth control pills, injections, patches, vaginal rings)",[],"* INCLUSION CRITERIA:\n\nInclusion Criteria for healthy volunteers (Groups 1 and 2)\n\n1. Male or female \\>=18 years of age at the time of consent and imaging.\n2. Provision of signed and dated informed consent form.\n3. Subjects must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. Adults lacking capacity will not be enrolled in this study.\n4. Stated willingness to comply with all study procedures and availability for the duration of the study.\n5. Generally healthy subjects based on medical history, physical examination, and laboratory testing, as determined by the PI.\n6. Female participants of childbearing potential must be using a medically acceptable means of contraception.\n\nInclusion Criteria for Patients with PROVEN or PROBABLE Aspergillosis or Mucormycosis Infections (Groups 3a and 3b)\n\n1. Male or female \\>=18 years of age at the time of consent and imaging.\n2. Provision of signed and dated informed consent form.\n3. Subjects must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. Adults lacking capacity will not be enrolled in this study.\n4. Stated willingness to comply with all study procedures and availability for the duration of the study.\n5. PROVEN or PROBABLE Invasive fungal disease (IFI), defined by the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium (EORTC\u002FMSGERC) \\[18\\].\n6. Female participants of childbearing potential must be using a medically acceptable means of contraception.\n\nFor inpatients, they should be determined by the attending of record to be stable to participate in the study (will be documented in the research records).\n\nInclusion Criteria for Participants with Non-Aspergillus\u002FNon-Mucorales Mold Infections (Group 4a) and Participants with Dimorphic Fungal Infections (Group 4b).\n\n1. Male or female \\>=18 years of age at the time of consent and imaging.\n2. Provision of signed and dated informed consent form.\n3. Subjects must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. Adults lacking capacity will not be enrolled in this study.\n4. Stated willingness to comply with all study procedures and availability for the duration of the study.\n5. Non-Aspergillus\u002Fnon-Mucorales mold infections including, but not limited to Cladophialophora spp., Dematiaceous molds (such as Curvularia, Scedosporium spp.) or dimorphic fungi (including, but not limited to Blastomyces spp., Coccidioides spp., Histoplasma spp. and Exophiala spp.).\n6. Female participants of childbearing potential must be using a medically acceptable means of contraception.\n\nFor inpatients, they should be determined by the attending of record to be stable to participate in the study (will be documented in the research records).\n\nAcceptable effective method of contraception (birth control) will include:\n\n* Partner vasectomy (making sterile)\n* Bilateral tubal ligation\n* Intrauterine devices (IUDs)\n* Hormonal implants (such as Implanon)\n* Other hormonal methods (birth control pills, injections, patches, vaginal rings)\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria for healthy subjects (Groups 1 and 2)\n\nComplete medical records will be reviewed, and within 1-3 months prior to the planned imaging, a complete blood count with differential and blood comprehensive metabolic panel will be performed. Subjects will be excluded from enrollment if any of the following apply:\n\n1. Clinically significant abnormalities on EKG or laboratory testing (blood and urine tests) as judged by the principal investigator.\n2. Reported pregnancy or pregnancy as determined by positive or indeterminate serum human Chorionic Gonadotrophin (hCG) or urine pregnancy tests prior to radiopharmaceutical dosing.\n3. Lactating females.\n4. History of uncontrolled diabetes mellitus.\n5. Lack of adequate venous access.\n6. Previous nuclear imaging or therapy administered within 5 physical half-lives of the used radioisotope prior to study enrollment.\n7. Inability to lie flat on the PET\u002FCT bed for the planned duration of scan, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).\n8. NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.\n\nExclusion Criteria for with PROVEN or PROBABLE Aspergillosis or Mucormycosis infections (Groups 3a and 3b) and non-Aspergillus\u002Fnon-Mucorales mold (Group 4a) or dimorphic fungal infections (Group 4b)\n\nComplete medical records will be reviewed, and within 28 days prior to imaging, a complete blood count with differential and blood comprehensive metabolic panel will be performed (unless already performed by the referring team as part of clinical evaluation). Subjects will be excluded from enrollment if any of the following apply:\n\n1. Abnormalities on laboratory testing judged by the principal investigator to affect the reliability or safe performance of the scan.\n2. Participants with severe hepatic and\u002For renal failure as determined by the primary clinical team\n3. Reported pregnancy or pregnancy as determined by positive or indeterminate serum human chorionic gonadotrophin (hCG) or urine pregnancy tests prior to radiopharmaceutical dosing.\n4. Lactating females.\n5. History of uncontrolled diabetes mellitus.\n6. Lack of adequate venous access.\n7. Previous administration of a radioisotope within 5 physical half-lives prior to study enrollment.\n8. Inability to lie flat on the PET\u002FCT bed for the planned duration of scan, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":94},"National Institutes of Health Clinical Center","Bethesda","Maryland","20892","United States",[88],{"name":89,"role":90,"phone":91,"phoneExt":92,"email":93},"NIH Clinical Center Office of Patient Recruitment (OPR)","CONTACT","800-411-1222","TTY dial 711","ccopr@nih.gov",{"lat":95,"lon":96},38.98067,-77.10026,[98],{"name":99,"role":90,"phone":100,"email":101},"Dima A Hammoud, M.D.","(301) 402-3041","hammoudd@cc.nih.gov",[103],{"name":99,"affiliation":13,"role":104},"PRINCIPAL_INVESTIGATOR",[],[107],{"label":108,"url":109},"NIH Clinical Center Detailed Web Page","https:\u002F\u002Fclinicalstudies.info.nih.gov\u002Fcgi\u002Fdetail.cgi?A_002488-CC.html",{"nct_id":4,"conditions":111,"biomarkers":122},[112,113,114,115,116,117,118,119,120,121],"Aspergillosis","Blastomycosis","Cladophialophora Infection","Coccidioidomycosis","Curvularia Infection","Exophiala Infection","Histoplasmosis","Invasive fungal infection","Scedosporiosis","Zygomycosis",[],{"nct_id":4,"found":67,"summary":124,"prompt_version":134},{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study with a planned enrollment of 100 participants. It includes both healthy volunteers and individuals with various mold infections.","completed","Investigating [18F]-Fluorocellobiose for Fungal Infection Detection","This study is testing a new imaging agent called [18F]-Fluorocellobiose ([18F]FCB) to see if it can help find fungal infections in the body using PET\u002FCT scans. Fungal infections can be serious, and currently, there isn't a good way to see them with imaging. Researchers want to understand how [18F]FCB moves through the body in healthy volunteers and if it collects in areas with mold infections like Aspergillosis or Mucormycosis. The main goal is to measure how much [18F]FCB gathers at the site of a suspected mold infection. The study is looking for 100 participants, including healthy volunteers and people aged 18 to 100 years who have fungal infections. The current recruitment status is unclear.","The primary endpoint, measuring SUV values, will be assessed at 3 years.",114,"Participants will have 3 clinic visits. The first visit will be for screening.","Not stated in the trial record.",[27],"v2"]