[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441609":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":40,"locations":48,"responsibleParty":69,"collaborators":10,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":10,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":10,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Zhongnan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"68Ga-DOTA-FAPI and 18F-FDG PET\u002FCT",null,"Investigators recruit patients whom are clinically highly suspected oral cancer or recurrence after treatment. Patients undergo baseline 68Ga-FAPI and 18F-FDG PET\u002FCTwithin one week. For resectable locally advanced cases receiving neoadjuvant therapy from oral and maxillofacial clinicians, a follow-up FAPI PET imaging will be performed after two cycles of treatment and before surgery.",[13,14,15],"Drug: 68Ga-DOTA-FAPI","Device: PET\u002FCT","Diagnostic Test: Participants receive baseline paired FDG and FAPI PET\u002FCT. For resectable locally advanced cases receiving neoadjuvant therapy undergo follow-up FAPI PET imaging.",[17,24,31],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","68Ga-DOTA-FAPI","Intravenous access is pre-established. Quality control is carried out to confirm the radiochemical purity of 68Ga-DOTA-FAPI by HPLC. Intravenous administration of 68Ga-DOTA-FAPI according to 1.85-3.7 MBq\u002Fkg body weight (0.05-0.1 mCi\u002Fkg), rinsed with 0.9% saline, and hydrated after drinking more water.",[9],[23],"gallium-68 (68Ga)-Fibroblast activation protein inhibitor (FAPI)",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","PET\u002FCT","Each subject undergoes PET\u002FCT imaging within 20-30 minutes after injection.",[9],[30],"Positron Emission Tomography\u002FComputed Tomography",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"DIAGNOSTIC_TEST","Participants receive baseline paired FDG and FAPI PET\u002FCT. For resectable locally advanced cases receiving neoadjuvant therapy undergo follow-up FAPI PET imaging.","This observational study evaluates the application of paired FDG and FAPI PET\u002FCT in oral cancer.\n\n1. Baseline phase: All participants undergo baseline FDG and FAPI PET\u002FCT scans.\n2. Post-neoadjuvant phase: For patients with resectable locally advanced disease receiving neoadjuvant therapy (as per clinician decision), a second FAPI PET\u002FCT scan is performed after 2 cycles of treatment to assess treatment response.\n3. Purpose: To explore the utility of FAPI PET in (a) initial staging, (b) treatment response evaluation, and (c) prognostic value in oral cancer.",[9],[37],{"name":38,"affiliation":5,"role":39},"He Yong, PhD","STUDY_CHAIR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":10,"email":45},"Jiang Yaqun, PhD","CONTACT","0086-027-67812698","zn004239@whu.edu.cn",{"name":38,"role":43,"phone":44,"phoneExt":10,"email":47},"vincentheyong@163.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Zhongnan Hopital of Wuhan University","RECRUITING","Wuhan","Hubei","430071","China","CN",{"type":58,"coordinates":59},"Point",[60,61],114.26667,30.58333,{"lat":61,"lon":60},[64,67],{"name":65,"role":43,"phone":66,"phoneExt":10,"email":45},"Yaqun Jiang, PhD, MD","027-67812837",{"name":68,"role":43,"phone":66,"phoneExt":10,"email":47},"Yong He, PhD, MD",{"type":70,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100441609","exploring-the-application-value-of-pet-molecular-imaging-targeting-fap-in-oral-squamous-cell-carcinoma-100441609",false,"NCT05030597","Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma","FAPI-OSCC","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent;\n2. Aged 18\\~70 years;\n3. Clinically highly suspected oral cancer and recurrence after treatment (Newly diagnosed patients: Scheduled for surgery or neoadjuvant therapy followed by surgery);\n4. Ability to complete baseline and follow-up PET\u002FCT (Follow-up FAPI PET\u002FCT applies only to locally advanced patients undergoing neoadjuvant therapy.).\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women, or women planning pregnancy during the trial period;\n2. Known hypersensitivity to FAPI, FDG, or their components, or history of severe allergic reactions;\n3. People with poor general condition, their heart, lung, liver, kidney and other important organ functions cannot tolerate surgery;\n4. Before the injection of 18F-FDG, the fasting blood glucose level exceeded 11.0 mmol\u002FL;\n5. Claustrophobia or inability to tolerate PET\u002FCT imaging (Those who cannot tolerate lying supine for 15\\~30 minutes.);\n6. Participation in another interventional clinical trial within 30 days prior to enrollment, or planned participation during this study.","ALL","18 Years","70 Years",{"count":82,"type":83},100,"ESTIMATED","OBSERVATIONAL","In this prospective study, the investigators will use integrated PET\u002FCT with the agent 68Ga-FAPI and conventional imaging agent 18F-FDG to explore the application value of FAP-targeted molecular imaging in the diagnosis and staging for oral cancer. This study also aims to explore the application value of FAPI imaging in evaluating treatment response for oral cancer.",[26,87,88],"FAPI","Oral Cancer","2025-05-21",{"date":91,"type":92},"2025-05-28","ACTUAL",{"date":94,"type":92},"2021-09-15",{"date":96,"type":83},"2025-12-31",{"name":5,"class":6},1]