[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"squamous-cell-carcinoma-mouth\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:squamous-cell-carcinoma-mouth":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,59,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":36,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100628371","phase-1-safety-and-feasibility-of-nivolumab-irdye800cw-in-patients-with-head-and-neck-squamous-cell-carcinoma-hnscc-100628371",false,"NCT07460765","Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Written informed consent\n* Age ≥ 18 years\n* Participants must have biopsy proven HNSCC or imaging of diagnostic of recurrent cancer or undergoing surgical excision for presumed HNSCC.\n* Adequate hematologic and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion).\n* Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)\u002FZubrod level 0-2.\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n\nExclusion Criteria:\n\n* Patients not planning for SOC surgical resection\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, HIV, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:\n\n  1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:\n\n     1. Rash must cover \\\u003C 10% of body surface area\n     2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n     3. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months\n* History of hepatitis C that has not been treated with curative intent.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan on active systemic therapy.\n* History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n* Severe unresolved infection within 4 weeks prior to initiation of study treatment.\n* Prior allogeneic stem cell or solid organ transplantation.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:\n\n  1. Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.\n  2. Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n  3. Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or steroid injections may participate. Pulse oral steroids of ≤5 days is permitted if \\>30 days from first infusion.\n  4. Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.\n  5. Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.\n* Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study drug administration.\n* Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This is a phase 1, open-label, single-center study that plans to enroll 40 participants who will undergo surgical resection as SOC for HNSCC. This trial is designed to evaluate the safety of the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent. The study employs a dose-escalation design across four cohorts of 10 participants each. Participants in Cohorts 1-3 will receive an infusion of nivo followed by an infusion of nivo800 prior to standard-of-care surgical resection. The administration of unlabeled nivo will be administered approximately 2-3 weeks before surgery, followed by an administration of nivo800 administered 1-2 days prior to surgery.",[25,26,27,28,29,30,31,32,33,34,35],"Hnscc","Head and Neck","Squamous Cell Cancer","Squamous Carcinoma","Squamous Cell Cancer of Head and Neck (SCCHN)","Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)","Squamous Cell Carcinoma Mouth","Squamous Carcinoma Poorly Differentiated","Squamous Cell Cancer of the Head and Neck","Squamous Cell Carcinoma (SCC) of the Oral Cavity","Squamous Cell Carcinoma (SCC)",[37,38,39,40,41,42,43,44,45],"nivo800","neoadjuvant","surgery","head and neck cancer","head and neck","surgical resection","oral cancer","SCC","HNSCC","RECRUITING","2026-06-26",{"date":49,"type":50},"2026-06-30","ACTUAL",{"date":52,"type":19},"2026-07",{"date":54,"type":19},"2031-04",{"name":56,"class":57},"Vanderbilt-Ingram Cancer Center","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":20,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":58},"100635632","pilot-study-of-bone-mineral-density-changes-during-anti-pd-1-immunotherapy-100635632","NCT07555210","Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy","Pilot Study Assessment of Bone Mineral Density Changes During Treatment With Anti-PD-1 Immunotherapy Agents","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients planning to start or within the first four weeks of treatment with anti-PD-1 immune checkpoint inhibitor therapy either alone or in combination with chemotherapy for curative intent for a known cancer diagnosis (use of immunotherapy must be FDA-approved and not experimental).\n3. Life expectancy of at least 12 months per the discretion of the treating physician.\n\nExclusion Criteria:\n\n1. Patients ineligible for anti-PD-1 therapy.\n2. Patients with metastatic disease.\n3. Patients planning treatment with dual immune checkpoint inhibitor therapy.\n4. Bony fractures in the pelvis, bilateral hips\u002Ffemurs, thoracic spine, or lumbar spine.\n5. Known osteoporosis or osteopenia.\n6. Planned or previous treatment with denosumab, zoledronic acid, or other bisphosphonate therapy in the last six months.\n7. Parathyroid gland disorders, rheumatoid arthritis (unless well-controlled off active biologic therapy without chronic steroid use), CKD stage IV\u002FV, or ESRD.\n8. Inability to comply with study procedures.\n9. Inability to lie flat for 20-25 minutes during an imaging session.\n10. Pregnant or breastfeeding patients.\n11. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.",{"count":67,"type":19},25,[69],"NA","Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment and work by blocking protein interactions that normally prevent the immune system from recognizing and destroying cancer cells. However, these agents, now approved for over 15 types of cancers and for both early-stage and metastatic disease, are capable of causing inflammation in any organ system of the body that can lead to organ damage, dysfunction, and even death in rare cases. Some patients may suffer acute and treatable complications like joint pain, but some may have irreversible complications like hypothyroidism that requires daily, life-long medication. It is therefore important to fully understand the different types of damage ICIs can cause to better monitor patients receiving ICI therapy.\n\nA rising concern from recent reports in the literature is that ICIs may weaken bone and increase the risk of fractures. In this study, the investigators aim to characterize how ICIs impact the bone by examining several factors in patients undergoing curative-intent ICI treatment either alone or in combination with chemotherapy: bone mineral density, bone volume, and markers of bone turnover in the blood. The study will use two imaging techniques to assess bone mineral density and volume. DXA (dual X-ray absorptiometry) imaging uses low-dose X-rays to measure how dense (or strong) bones are and is often used to diagnose or assess the risk of osteoporosis. High-resolution peripheral quantitative computed tomography (HRpQCT) is a 3D imaging technology that can quantify bone structure and volume and offers high resolution that can be used to assess bone in smaller bones of the peripheral skeleton.\n\nThe investigators hypothesize that ICI treatment will weaken bones and increase the risk of fractures. As ICI therapy is relatively new, a rising number of patients may be at risk of fractures or have low bone density that is not being monitored because there are no guidelines in place notifying physicians of this potential risk to patients. This is study will provide important preliminary data that will be the basis for larger studies in the future aiming to better monitor and potentially treat bone weakening in patients treated with ICIs to reduce the pain, inconvenience, and complications from fragility fractures.",[72,73,74,75,76,31,77,78],"Breast Cancer (Triple Negative Breast Cancer (TNBC))","Renal Cell Carcinoma (Kidney Cancer)","Melanoma (Skin Cancer)","Non-Small Cell Lung Cancer","MSI-H\u002FdMMR Rectal Cancer","Invasive Mammary Carcinoma","Classic Hodgkin Lymphoma","2026-05-04",{"date":81,"type":50},"2026-05-06",{"date":83,"type":50},"2025-08-25",{"date":85,"type":19},"2028-07-01",{"name":87,"class":57},"Jessica Mezzanotte Sharpe",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":96,"phases":4,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":58},"100602753","primary-tumor-depth-of-invasion-and-lymph-node-management-in-oral-squamous-cell-carcinoma-100602753","NCT07127614","Primary Tumor Depth of Invasion and Lymph Node Management in Oral Squamous Cell Carcinoma","The Relationship Between Primary Tumor Depth of Invasion and Neck Lymph Nodes Management in T1T2N0 Oral Cavity Squamous Cell Carcinomas","Inclusion Criteria:\n\n* Patients with biopsy-proven oral squamous cell carcinoma with the edition T1or T2 N0 based on TNM staging by the American Joint Cancer Center AJCC 8th edition\n* The primary tumor has a depth of invasion (DOI) greater than 4 mm\n* Clinical N0 status confirmed by reasonable parameters includes computed tomography CT, MRI, -Ultrasonography,( US fine needle aspiration in suspected lymph nodes )\n* The primary tumor must be reliably resected to a clear margin without the need for entry of the neck for reconstruction\n\nExclusion Criteria:\n\n* Patients with T3T4 OCSCC\n* Proven or suspected positive neck node\n* Patient with distant metastasis\n* Patient with gross injury to the neck that precludes proper surgical dissection.\n* Patient with a history of radiotherapy to the neck\n* Recurrent cases of OCSCC or recurrent node disease\n* Patient with previous neck node biopsy or previous neck dissection\n* Patient with a medical condition or performance that interferes with the surgical intervention as judged by the specialist physician",{"count":67,"type":19},"OBSERVATIONAL","To evaluate the diagnostic accuracy of preoperative MRI in the determination of the primary tumor depth of invasion (DOI) as a predictor factor in neck lymph nodes management in T1T2N0 oral cavity squamous cell carcinomas as compared to the pathological depth of invasion",[31],[100,101,102],"squamous cell carcinoma","MRI","diagnostic accuracy","NOT_YET_RECRUITING","2025-08-14",{"date":106,"type":50},"2025-08-17",{"date":108,"type":19},"2025-08-10",{"date":110,"type":19},"2026-01",{"name":112,"class":57},"Al-Azhar University"]