[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07132645":3,"trial-entities:NCT07132645":126,"trial-summary:NCT07132645":130},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":68,"secondary_outcomes":75,"sex":84,"minimum_age":85,"maximum_age":17,"healthy_volunteers":86,"eligibility_criteria":87,"std_ages":100,"locations":103,"central_contacts":121,"overall_officials":122,"references":124,"see_also_links":125},"NCT07132645","UMCC 2024.069","An Investigational Scan ([68Ga] Ga-FAPI-04 PET\u002FCT) for the Imaging of Patients With High-Grade Neuroendocrine Cancer","An Exploratory Study of [68Ga]Ga-Fibroblast Activation Protein Inhibitor 4 ([68Ga]Ga-FAPI-04) in Patients With High-Grade Neuroendocrine Neoplasms","RECRUITING","2027-09-01","2026-07","2026-07-31","2025-09-16","University of Michigan Rogel Cancer Center","OTHER",true,"This early phase I trial determines where and to what degree the tracer \\[68Ga\\] Ga-FAPI-04 accumulates in normal and cancer tissues in patients with high grade neuroendocrine cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research \\[68Ga\\] Ga-FAPI-04. Because some cancers take up \\[68Ga\\] Ga-FAPI-04, it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body.",null,[19],"Neuroendocrine Tumor",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"EARLY_PHASE1",{"count":26,"type":27},30,"ESTIMATED",[29,46,56],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"PROCEDURE","Computed Tomography","Undergo CT scan",[34],"Basic science ([68Ga] Ga-FAPI-04)",[36,37,38,39,40,41,42,43,44,45],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","tomography",{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"DRUG","Gallium Ga 68-DOTA-FAPI-04","Given IV",[34],[52,53,54,55],"68Ga-DOTA-FAPI-04","68Ga-FAPi-04","GALLIUM GA-68-DOTA-FAPI-04","Gallium-68-FAPi-04",{"type":30,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Positron Emission Tomography","Undergo PET scan",[34],[61,62,63,64,65,66,67],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",[69,72],{"measure":70,"timeFrame":71},"Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)","Day 1",{"measure":73,"description":74,"timeFrame":71},"Pharmacokinetics of [68Ga] Ga-FAPI-04","We will monitor\u002Fmeasure the amount of Ga-FAPI-04 seen within different tissue in patients that have neuroendocrine tumors. We will specifically measure the ratio of uptake in the tumors in comparison to reference tissues such as liver or muscle.",[76,78,81],{"measure":77,"timeFrame":71},"Tissue concentrations of [68Ga] Ga-FAPI-04 retention in tumors",{"measure":79,"description":80,"timeFrame":71},"Standardized uptake values (SUV) of [68Ga] Ga-FAPI-04 retention in tumors","Will compare the difference in SUVmax uptake within each subject using a two-side, one-sample t-test.",{"measure":82,"description":83,"timeFrame":71},"Clinical diagnostic performance of [68Ga] Ga-FAPI-04","When a comparison Ga-DOTATATE scan is available, we will look at the uptake in the tumor in the SOC image related to reference tissue and then compare the FAPI-04 uptake.","ALL","18 Years",false,{"inclusion":88,"exclusion":96,"raw_text":99},[89,90,91,92,93,94,95],"Age ≥ 18 years old","Current neuroendocrine tumor diagnosis AND high-grade neuroendocrine tumor presentation determined using the following criteria(s):","Previous low uptake of \\[68Ga\\] Ga-DOTATATE PET\u002FCT scan OR","Krenning Score ≥ 3 OR","Ki67 index ≥ 20%","Able to lie flat for 60 minutes","Ability to understand and the willingness to sign a written informed consent",[97,98],"Pregnancy or lactation","Patient recently underwent surgery with wound healing","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Current neuroendocrine tumor diagnosis AND high-grade neuroendocrine tumor presentation determined using the following criteria(s):\n\n  * Previous low uptake of \\[68Ga\\] Ga-DOTATATE PET\u002FCT scan OR\n  * Krenning Score ≥ 3 OR\n  * Ki67 index ≥ 20%\n* Able to lie flat for 60 minutes\n* Ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Patient recently underwent surgery with wound healing",[101,102],"ADULT","OLDER_ADULT",[104],{"facility":105,"status":8,"city":106,"state":107,"zip":108,"country":109,"contacts":110,"geoPoint":118},"University of Michigan Comprehensive Cancer Center","Ann Arbor","Michigan","48109","United States",[111,116],{"name":112,"role":113,"phone":114,"email":115},"Benjamin Viglianti","CONTACT","734-936-5385","bviglia@med.umich.edu",{"name":112,"role":117},"PRINCIPAL_INVESTIGATOR",{"lat":119,"lon":120},42.27756,-83.74088,[],[123],{"name":112,"affiliation":13,"role":117},[],[],{"nct_id":4,"conditions":127,"biomarkers":128},[19],[129],"MKI67 Gene",{"nct_id":4,"found":15,"summary":131,"prompt_version":141},{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is an interventional study with a planned enrollment of 30 participants. It is an early phase trial, meaning it's focused on understanding how the investigational scan works in the body.","completed","Investigating [68Ga]Ga-FAPI-04 PET\u002FCT for High-Grade Neuroendocrine Cancer","This study is testing an investigational scan called [68Ga]Ga-FAPI-04 PET\u002FCT for people with high-grade neuroendocrine cancer. Researchers want to see where the imaging agent, Gallium Ga 68-DOTA-FAPI-04, goes in the body and how it moves through the system. This helps them understand if it can effectively highlight cancer cells. You might be able to join if you are 18 or older, have a high-grade neuroendocrine tumor, and can lie flat for 60 minutes. The study aims to enroll 30 participants. The current recruitment status is unclear.","Your biodistribution and pharmacokinetics (how the drug moves through your body) will be measured on Day 1.",86,"You would undergo a CT scan and a PET scan, which involves receiving Gallium Ga 68-DOTA-FAPI-04 intravenously (IV).","Not stated in the trial record.",[48],"v2"]