[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605919":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":22,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":22,"enrollmentInfo":75,"targetDuration":22,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":89,"whyStopped":22,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Indiana University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"[18F]-AraG PET\u002FCT scan","EXPERIMENTAL","\\[18F\\]-AraG PET\u002FCT scans to be performed according to the institution's standard of operation, which occurs on the first and sixteenth day of treatment.",[13,14,15],"Drug: [18F]-AraG radiotracer","Drug: Chemotherapy","Device: Radiotherapy",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","[18F]-AraG radiotracer","\\[18F\\]-AraG radiotracer, which occurs on the first and sixteenth day of treatment.",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Chemotherapy","Concurrent chemoradiotherapy (CRT) with weekly doses of cisplatin.",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"DEVICE","Radiotherapy","Concurrent chemoradiotherapy (CRT) of 70Gy of radiation dose in 33 fractions.",[9],[33],{"name":34,"affiliation":35,"role":36},"Mark Langer","Indiana University Simon Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":22,"email":42},"Kathryn I Lauer","CONTACT","(317) 962-8969","kilauer@iu.edu",[44],{"facility":5,"status":22,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Indianapolis","Indiana","46202","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-86.15804,39.76838,{"lat":54,"lon":53},[57,58],{"name":39,"role":40,"phone":41,"phoneExt":22,"email":42},{"name":59,"role":36,"phone":22,"phoneExt":22,"email":22},"Mark Langer, MD",{"type":36,"investigatorFullName":34,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Professor of Clinical Radiation Oncology",[63],{"name":64,"class":65},"CellSight Technologies, Inc.","INDUSTRY","100605919","early-phase-1-18f-arag-pet-imaging-in-la-hnscc-100605919",false,"NCT07168785","[18F]-AraG PET Imaging in LA HNSCC","[18F]-AraG PET Imaging for Enhanced Risk Stratification and Chemoradiotherapy Response Assessment in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria\n\n1. Patients ≥18 years of age.\n2. Ability to provide written informed consent and HIPAA authorization.\n3. LA-HNSCC in the larynx, hypopharynx, or human papillomavirus (HPV) negative oropharynx and is planning to receive definitive CRT as the SOC treatment, which includes a total of 70 Gy of radiation dose in 33 fractions, delivered over 5 days a week for 7 weeks, as well as planned weekly cycles of cisplatin (CDDP).\n4. Tumor stage III and IV (AJCC 8th edition).\n5. Unresectable cases.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n7. Willing and able to maintain the imaging protocol.\n8. Patients planning to receive pre-CRT and post-CRT FDG PET\u002FCT scans as part of the standard clinical practice.\n\nExclusion Criteria\n\n1. Diagnosis of immunodeficiency or receiving systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the PET\u002FCT scan.\n2. Pregnant or breastfeeding.\n3. Patients that will receive definitive induction chemotherapy or surgery.\n4. Patients who are unable to complete the radiation therapy.","ALL","18 Years",{"count":76,"type":77},5,"ESTIMATED","INTERVENTIONAL",[80],"EARLY_PHASE1","This study will use \\[18F\\]-AraG PET\u002FCT scans to monitor patients who have been diagnosed with locally advanced Head and Neck Squamous Cell carcinoma (LA-HNSCC), and are planning to undergo standard of care chemoradiotherapy for treatment.",[83,84],"Head and Neck Squamous Cell Carcinoma (HNSCC)","Locally Advanced Head and Neck Squamous Cell Carcinoma",[86,87,88],"AraG PET\u002FCT","Chemoradiotherapy","[18F]-AraG PET\u002FCT","NOT_YET_RECRUITING","2025-09-04",{"date":92,"type":93},"2025-09-11","ACTUAL",{"date":95,"type":77},"2025-10-01",{"date":97,"type":77},"2027-10",{"name":5,"class":6},1]