[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585588":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":23,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":23,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":23,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":23,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":32,"whyStopped":23,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Nuclear Imaging Institute","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"ultralow dose PSMA imaging group","Healthy subjects and cancer patients will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours",[12],"Drug: Piflufolastat F18",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Piflufolastat F18","Participants will be injected with Piflufolastat F18 and imaged for up to 3 hours on a PET scanner",[9],[20,21,22],"CT scan","PET scan","blood collection",null,[25],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Barbara Blanchfield","CONTACT","9732554955","bblanchfield@nii.org",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Englewood","New Jersey","07631","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-73.97264,40.89288,{"lat":42,"lon":41},[45],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","Akiva Mintz","Executive Director","100585588","phase-2-ultralow-dose-pet-imaging-for-psma-expression-100585588",false,"NCT06904313","Ultralow Dose PET Imaging for PSMA Expression","Evaluation of Ultralow Dose PET Imaging for Detecting PSMA Expression","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Ability to provide informed consent and comply with study procedures.\n3. For female participants:\n\n   * Must not be pregnant or breastfeeding.\n   * Negative pregnancy test required for women of childbearing potential.\n\nExclusion Criteria:\n\n1. Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total).\n2. More than four prior enrollments in this study.\n3. Participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the PET scan\n4. Medication \\& Prior Treatment Exclusions\n\n   • Concurrent PSMA-targeted therapy (e.g., lutetium-177).\n5. Pregnant or breastfeeding individuals (negative pregnancy test required)\n6. Inability to provide informed consent\n7. Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.",true,"ALL","18 Years","120 Years",{"count":62,"type":63},200,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","The goal of this clinical trial is to evaluate an investigational ultralow dose PET imaging technique for prostate cancer detection and monitoring. The main question it aims to answer is:\n\nCan the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard?\n\nParticipants will be injected with a radioactive tracer called 18F-DCFPyL and be imaged on a new type of high sensitivity PET scanner for up to 3 hours",[69,70],"Healthy Volunteer","Prostate CA",[21,72,73,74],"prostate cancer","psma","nuclear imaging","2025-06-01",{"date":77,"type":78},"2025-06-04","ACTUAL",{"date":80,"type":78},"2025-05-12",{"date":82,"type":63},"2030-06-30",{"name":48,"class":6},1]