[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641329":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":70,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":36,"eligibilityCriteria":81,"healthyVolunteers":78,"sex":82,"minAge":83,"maxAge":36,"enrollmentInfo":84,"targetDuration":36,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":100,"whyStopped":36,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Newly Diagnosed HNSCC who are scheduled to undergo surgical resection","EXPERIMENTAL","Cohort 1 will undergo 64Cu-DOTA-ECL1i positron emission tomography-computed tomography (PET\u002FCT) once prior to scheduled standard of care (SOC) surgery and prior to any neoadjuvant therapy.\n\nParticipants will be followed up via a phone call or in-person visit 24 hours - 14 days after 64Cu-DOTA-ECL1i administration to assess for adverse events. Participants will be followed via medical chart review for standard of care clinical and radiological appointments.",[13],"Drug: 64Cu-DOTA-ECL1i",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: Recurrent\u002Fmetastatic HNSCC who are candidates for first-line anti-PD1 therapy","Cohort 2 subjects will undergo 64Cu-DOTA-ECL1i PET imaging twice, once at baseline prior to the start of anti-PD1 therapy and after 3 cycles of therapy (within 14 days of cycle 4 day 1).\n\nParticipants will be followed up via a phone call or in-person visit 24 hours - 14 days after baseline 64Cu-DOTA-ECL1i administration to assess for adverse events. Participants will be followed via medical chart review for standard of care clinical and radiological appointments.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","64Cu-DOTA-ECL1i","64Cu-DOTA-ECL1i a novel PET imaging tracer that will be provided intravenously (IV) while participants will be positioned supine on the on the scanning table. The injection will be followed with saline flush.",[9,15],[25,26,27],"Copper Cu 64-DOTA-ECL1i","64Cu-d(LGTFLKC)","Cu-64 DOTA-ECL1i",[29],{"name":30,"affiliation":5,"role":31},"Farrokh Dehdashti, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","314-362-1474",null,"dehdashtif@wustl.edu",[39],{"facility":5,"status":36,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"St Louis","Missouri","63110","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-90.19789,38.62727,{"lat":49,"lon":48},[52,53,56,58,60,62,64,66,68],{"name":30,"role":34,"phone":35,"phoneExt":36,"email":37},{"name":54,"role":55,"phone":36,"phoneExt":36,"email":36},"Yongjian Liu, PhD","SUB_INVESTIGATOR",{"name":57,"role":55,"phone":36,"phoneExt":36,"email":36},"Ryan Jackson, MD",{"name":59,"role":55,"phone":36,"phoneExt":36,"email":36},"Sidharth Puram, MD, PhD",{"name":61,"role":55,"phone":36,"phoneExt":36,"email":36},"Douglas Adkins, MD",{"name":63,"role":55,"phone":36,"phoneExt":36,"email":36},"Ningying Wu, MD, PhD",{"name":65,"role":55,"phone":36,"phoneExt":36,"email":36},"Chieh-Yu Lin, MD, PhD",{"name":67,"role":55,"phone":36,"phoneExt":36,"email":36},"Richard Laforest, PhD",{"name":69,"role":55,"phone":36,"phoneExt":36,"email":36},"Ying Hwey Nai, PhD",{"type":71,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[73],{"name":74,"class":75},"National Cancer Institute (NCI)","NIH","100641329","phase-2-ccr2-pet-imaging-head-and-neck-squamous-cell-carcinoma-100641329",false,"NCT07659678","CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Adult patient 18 years of age or older\n* Cohort 1: Newly diagnosed locally advanced T3-T4a, N0-3 and M0 squamous cell head and neck cancer scheduled to undergo standard of care surgery with or without neoadjuvant therapy OR Cohort 2: Suspected or biopsy proven recurrent\u002Fmetastatic squamous cell head and neck cancer scheduled to undergo first-line anti-PD1 therapy. HPV status does not need to be known and both HPV+ and HPV- subjects are eligible to enroll\n* Lesion size of at least 1.0 cm in longest dimension by conventional imaging.\n* Able to give informed consent\n* Not currently pregnant or nursing: Female subjects must be surgically sterile (has had a documented bilateral oophorectomy and\u002For documented hysterectomy), post- menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of Cu-DOTA-ECL1i is negative\n\nExclusion Criteria:\n\n* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 2 years\n* Unable to tolerate approximately 60 min (total time) of PET\u002FCT imaging","ALL","18 Years",{"count":85,"type":86},90,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","This is a prospective study to evaluate the sensitivity and specificity of Cu-64 DOTA-ECL1i PET\u002FCT imaging to serve as a novel precision imaging tool for patients with head and neck squamous cell carcinoma (HNSCC).",[92,93,94],"Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent\u002FMetastatic (R\u002FM)","Head and Neck Squamous Cell Carcinoma HNSCC",[96,97,98,99],"Head and neck cancer","P16+ and P16-","PET","CCR2","NOT_YET_RECRUITING","2026-06-15",{"date":103,"type":104},"2026-06-22","ACTUAL",{"date":106,"type":86},"2026-08-31",{"date":108,"type":86},"2032-03-31",{"name":5,"class":6},1]