[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07110519":3,"trial-entities:NCT07110519":93,"trial-summary:NCT07110519":97},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":69,"locations":72,"central_contacts":81,"overall_officials":82,"references":86,"see_also_links":87},"NCT07110519","PAKMANN","Positron Emission Tomography (PET) Contrast Agent Kinetics and Safety: [18F]-Fluoromannitol","ACTIVE_NOT_RECRUITING","2027-05","2026-08","2026-08-21","2025-09-17","St. Jude Children's Research Hospital","OTHER",false,"This is a Phase 0 interventional, non-therapeutic study investigating the biodistribution and safety of \\[18F\\]-fluoromannitol as a radiotracer (a substance used to help detect disease or infection) in Positron Emission Tomography (PET) scans.\n\nThe primary objective of this study is to generate safety data in healthy adult human volunteers. In the future, this tracer may help to determine if a medical problem is infectious in people who have Sickle Cell Disease, cancer or other conditions that impact the immune system, or with people who have joint implants.\n\nPrimary Objective\n\n\\- Generate safety data, biodistribution and perform human organ dosimetry for \\[18F\\]- fluoromannitol as a novel PET tracer.\n\nParticipants will be recruited primarily from St. Jude Children's Research Hospital employees and SJLIFE participants, and from the broader Memphis community if needed.","This study is designed to evaluate the safety and movement throughout the body of 18F-FMtl in healthy adult volunteers. It will be conducted under an IND approved by the FDA. The IND is required as 18F-fMtl is not commercially available and has not been studied in humans.\n\nThe design for this phase 0 study will be a single-group prospective trial.\n\nPrimary intervention is the administration of intravenous \\[18F\\]-fluoromannitol as a radiotracer with subsequent PET scans. Associated interventions include collection of blood and urine samples, vital signs, and symptoms from participants.",[18],"Healthy",[18,20,21,22],"Adult","Age 18-75 years","Volunteer","INTERVENTIONAL","DIAGNOSTIC",[26],"EARLY_PHASE1",{"count":28,"type":29},11,"ACTUAL",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","[18F]-fluoromannitol","\\[18F\\]-fluoromannitol is an investigational, novel radiotracer for use with PET scan imaging to help detect disease or infection.",[36],"Participants",[38,42],{"measure":39,"description":40,"timeFrame":41},"Evaluate safety of [18F]fluoromannitol administration in up to 10 human subjects.","Safety will be assessed by the number and percentage of patients with adverse events following \\[18F\\]fluoromannitol administration. Adverse events will be categorized by the FDA's Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.","Baseline at study entry and within 4 days following PET\u002FCT.",{"measure":43,"description":44,"timeFrame":45},"Evaluate the biodistribution of [18F]fluoromannitol in up to 10 human subjects.","Calculate the absorbed dose of \\[18F\\]fluoromannitol in normal organs.","Through study completion, with an average of 3 months post-PET\u002FCT.",[],"ALL","18 Years","75 Years",true,{"inclusion":52,"exclusion":55,"raw_text":68},[53,54],"Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.","Informed consent signed by participant according to the guidelines of the institutional review board.",[56,57,58,59,60,61,62,63,64,65,66,67],"Participant currently has a fever or other symptoms concerning for an active infection or is currently undergoing treatment for an active infection.","Participant has been diagnosed and\u002For treated for a known or suspected bacterial infection within the past 60 days.","Participant has known disease of the lung, liver, kidneys, gastrointestinal tract, bones\u002Fjoints, or known immune suppression or autoimmune disease that is likely to have active inflammation (examples to exclude: Crohn's disease, COPD; example to i include: well controlled asthma)","Participant has prosthetic or indwelling device(s) currently or has had one in the past 60 days.","Participant is pregnant or breastfeeding.","Use of drugs known to have interaction or be affected by mannitol within 60 days of enrollment.","Participant has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol, including being unable to tolerate the PET scan procedures.","Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.","Participant is currently participating in another study subject to an IND.","Estimated glomerular filtration rate is \\\u003C 45 ml\u002Fminute\u002F1.73m2","Positive pregnancy test (females only)","One or more of the results from laboratory (hematology, chemistries, inflammatory markers), vital signs, or ECG specified in the schedule of evaluations is outside the normal institutional range AND is clinically significant in the opinion of the investigator.","Inclusion Criteria:\n\nHealthy volunteers, 18-75 years of age.\n\n* Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.\n* Informed consent signed by participant according to the guidelines of the institutional review board.\n\nExclusion Criteria:\n\nInitial Eligibility Exclusion Criteria (Entry to Screening Phase -\n\n* Participant currently has a fever or other symptoms concerning for an active infection or is currently undergoing treatment for an active infection.\n* Participant has been diagnosed and\u002For treated for a known or suspected bacterial infection within the past 60 days.\n* Participant has known disease of the lung, liver, kidneys, gastrointestinal tract, bones\u002Fjoints, or known immune suppression or autoimmune disease that is likely to have active inflammation (examples to exclude: Crohn's disease, COPD; example to i include: well controlled asthma)\n* Participant has prosthetic or indwelling device(s) currently or has had one in the past 60 days.\n* Participant is pregnant or breastfeeding.\n* Use of drugs known to have interaction or be affected by mannitol within 60 days of enrollment.\n* Participant has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol, including being unable to tolerate the PET scan procedures.\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.\n* Participant is currently participating in another study subject to an IND.\n\nFinal Eligibility Exclusion Criteria (Entry to Study):\n\nAt the time of the Final Eligibility Determination (Imaging Study Visit 1):\n\n* Participant no longer meets one or more of the Inclusion Criteria\n* Participant now fails one or more of the Initial Eligibility Exclusion Criteria\n* Estimated glomerular filtration rate is \\\u003C 45 ml\u002Fminute\u002F1.73m2\n* Positive pregnancy test (females only)\n* One or more of the results from laboratory (hematology, chemistries, inflammatory markers), vital signs, or ECG specified in the schedule of evaluations is outside the normal institutional range AND is clinically significant in the opinion of the investigator.\n\nRe-screening will not be allowed unless the Investigator considers the cause of the initial screen failure to be of an acute and\u002For completely reversible nature.",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":12,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Memphis","Tennessee","38105","United States",{"lat":79,"lon":80},35.14953,-90.04898,[],[83],{"name":84,"affiliation":12,"role":85},"Kiel J Neumann, PhD","PRINCIPAL_INVESTIGATOR",[],[88,90],{"label":12,"url":89},"http:\u002F\u002Fwww.stjude.org",{"label":91,"url":92},"Clinical Trials Open at St. Jude","http:\u002F\u002Fwww.stjude.org\u002Fprotocols",{"nct_id":4,"conditions":94,"biomarkers":96},[95],"Healthy Volunteer",[],{"nct_id":4,"found":50,"summary":98,"prompt_version":108},{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is a Phase 0 study, meaning it's an early look at a new substance. It's a single-group study, meaning all participants will receive the same intervention.","completed","Investigating [18F]-Fluoromannitol for PET Scans","This study is looking at a new substance called [18F]-fluoromannitol, which is used with PET scans (a type of imaging that helps detect disease or infection). Researchers want to understand how safe [18F]-fluoromannitol is and how it moves through the body in healthy adults. This information could eventually help doctors detect infections in people with conditions like Sickle Cell Disease, cancer, or those with joint implants. The study aims to gather safety data from up to 10 healthy volunteers. We are currently recruiting participants for this study.","Your safety will be checked within 4 days after the PET\u002FCT scan. The study will track how [18F]-fluoromannitol moves through your body until the study ends, which is an average of 3 months after your PET\u002FCT scan.",87,"You would receive an intravenous (into a vein) injection of [18F]-fluoromannitol and have PET scans. Blood and urine samples will be collected, and your vital signs and symptoms will be monitored.","Not stated in the trial record.",[33],"v2"]