[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-and-neck-cancer-hn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-and-neck-cancer-hn":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,53,83,112,142,171,204,238],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100644983","oral-fecal-and-intratumoral-microbiome-atlas-in-colombian-patients-with-advanced-solid-tumors-receiving-first-line-immunotherapy-100644983",false,"NCT07676461","Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy","Atlas of the Oral, Fecal and Intratumoral Microbiome of Colombian Patients With Advanced Solid Tumors Candidates for First-Line Immunotherapy - Initial Phase of a Project With Latin American Projection","ATLAS","Inclusion Criteria:\n\n* Age 18 years or older.\n* Histologically confirmed advanced (stage III unresectable or IV) gastric, colorectal, breast, cervical or head-and-neck cancer.\n* Candidate for first-line immunotherapy per current clinical guidelines.\n* Available FFPE tumor block in institutional or reference pathology archive.\n* Able to provide saliva and stool samples at V0 and follow-up.\n* ECOG performance status within protocol limits; life expectancy over 3 months.\n* Cognitive capacity to give informed consent; signed EVA-BIOBANCO and Atlas consents.\n\nInclusion Criteria (healthy controls)\n\n* No prior cancer diagnosis.\n* No active autoimmune disease; no inflammatory bowel disease.\n* No antibiotics, invasive dental treatment, immunosuppressants or corticosteroids in the prior 3 months; no severe active periodontal disease.\n\nExclusion Criteria:\n\n* Systemic antibiotics within 3 months (except short course under 5 days for uncomplicated infection).\n* Probiotics or prebiotics within 30 days.\n* Chronic proton-pump inhibitors for more than 3 continuous months.\n* Inflammatory bowel disease (Crohn, ulcerative colitis) or extensive bowel resection.\n* Pregnancy or lactation.\n* BMI under 18.5 or over 40 kg\u002Fm².\n* Uncontrolled diabetes (HbA1c at or above 9% in prior 3 months).\n* Invasive dental treatment within 3 months.\n* Patients: simultaneous randomized trial of a non-INVIMA-approved experimental immunotherapy; or no evaluable FFPE block meeting quality thresholds.\n* Inability to ensure 12-month clinical follow-up.",true,"ALL","18 Years",{"count":21,"type":22},150,"ESTIMATED","OBSERVATIONAL","This is a prospective observational cohort study conducted at Fundación CTIC in Bogotá, Colombia. It characterizes the oral, fecal and intratumoral microbiome of Colombian adults with advanced solid tumors (gastric, colorectal, breast, cervical and head-and-neck cancer) who receive first-line immunotherapy as standard of care, and compares them with healthy volunteers. Using multi-omics (HiFi metagenomics, 16S, tumor RNA-Seq and untargeted metabolomics), the study aims to identify microbial signatures associated with treatment response and survival, building the initial Colombian cohort of a Cancer Microbiome Atlas with Latin American projection.",[26,27,28,29,30],"Gastric Cancer","Colorectal Cancer","Breast Cancer","Cervical Cancer","Head and Neck Cancer (H&N)",[32,33,34,35,36,37,38,39],"Microbiome","Cancer","Immunotherapy","Tumor microenvironment","Biomarkers","Metagenomics","Transcriptomics","Metabolomics","RECRUITING","2026-06-24",{"date":43,"type":44},"2026-06-30","ACTUAL",{"date":46,"type":44},"2026-06-11",{"date":48,"type":22},"2029-08-30",{"name":50,"class":51},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100643228","early-phase-1-evaluation-of-galuht547-safety-biodistribution-and-dosimetry-in-solid-tumors-100643228","NCT07639970","Evaluation of [⁶⁸Ga\u002F¹⁷⁷Lu]HT547: Safety, Biodistribution, and Dosimetry in Solid Tumors","Evaluation of the Safety, Biodistribution and Human Dosimetry of [68Ga]Ga-HT547 PET\u002FCT and [177Lu]Lu-HT547 SPECT\u002FCT in the Clinical Diagnosis of Solid Tumor Patients","Inclusion Criteria:\n\n1. Willing and able to communicate with the investigator, understand and comply with trial requirements, voluntarily participate in the trial, and provide written informed consent.\n2. Aged 18 years or older, regardless of gender.\n3. Expected survival of at least 3 months.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n5. Patients with solid tumors (breast cancer, head and neck cancer, pancreatic cancer, or brain glioma) confirmed by histology or cytology.\n6. Radiographic evidence of disease progression within 12 months prior to screening (according to RECIST 1.1 criteria).\n7. At least one measurable target lesion according to RECIST 1.1 criteria.\n8. Positive uptake in the target lesion on ⁶⁸Ga-HT547 Positron Emission Tomography (PET) scan, with SUV ≥ 4.\n9. Recovery from toxicities related to prior therapy to ≤ Grade 1 or baseline (except for alopecia, vitiligo, etc.).\n10. For subjects of childbearing potential: Agreement to remain abstinent or use effective contraception (including intrauterine devices, etc.) from signing the ICF until at least 24 weeks after the last dose.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women, or women with a positive baseline pregnancy test.\n2. History of severe allergic reaction to any component of the investigational drug injection.\n3. Received blood transfusion within 4 weeks prior to screening to meet the enrollment criteria.\n4. Received immunotherapy, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks prior to the first dose.\n5. Received any investigational drug within 28 days prior to the first dose, or concurrent participation in another clinical study (except: participation in an observational, non-interventional study, or being in the follow-up phase of an interventional study).\n6. History of other known malignancies within the past 5 years.\n7. Presence of symptomatic or unstable third-space effusions (e.g., pleural effusion, ascites, pericardial effusion) requiring repeated drainage.\n8. Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.\n9. Inadequate organ function (meeting any of the following):\n\n   1. Bone marrow reserve: Neutrophil count \\\u003C 1.5 x 10⁹\u002FL, or platelet count \\\u003C 100 x 10⁹\u002FL, or hemoglobin \\\u003C 90 g\u002FL.\n   2. Liver function: AST\u002FALT \\> 3 x ULN (\\> 5 x ULN for subjects with liver metastases), or albumin ≤ 2.8 g\u002FdL, or total bilirubin \\> 1.5 x ULN.\n   3. Renal function: Serum creatinine \\> 1.5 x ULN and creatinine clearance \\\u003C 60 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n10. Severe cardiovascular clinical diseases or symptoms that may increase subject safety risk, including:\n\n    1. Congestive heart failure (New York Heart Association \\[NYHA\\] class \\> II) within the past year.\n    2. Unstable angina within the past year.\n    3. Myocardial infarction within the past year.\n    4. Clinically significant malignant arrhythmia (except for atrial fibrillation, paroxysmal supraventricular tachycardia).\n    5. Presence of clinically significant QTcF prolongation (QTcF \\> 470 ms, calculated by Fridericia's formula).\n11. Clinically significant bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage) within 14 days prior to the first dose.\n12. Major surgery or significant trauma within 28 days prior to the first dose.\n13. Any other condition that, in the investigator's judgment, may increase safety risk or interfere with its interpretation.\n14. Inability of the subject to understand and comply with study instructions and requirements.\n15. Any other situation deemed inappropriate by the investigator.","90 Years",{"count":62,"type":22},20,"INTERVENTIONAL",[65],"EARLY_PHASE1","Urokinase plasminogen activator receptor (uPAR), the cell-surface receptor for its ligand uPA, plays a critical role in regulating cell migration and invasion-key drivers of cancer progression. This study aims to evaluate a novel uPAR-targeting radiopharmaceutical pair: the diagnostic agent \\[⁶⁸Ga\\]Ga-HT547 and the therapeutic agent \\[¹⁷⁷Lu\\]Lu-HT547. In patients with breast cancer, head and neck cancer, pancreatic cancer, or glioma, we will assess the diagnostic performance and biodistribution of these tracers using \\[⁶⁸Ga\\]Ga-HT547 and \\[¹⁷⁷Lu\\]Lu-HT547 SPECT\u002FCT.",[28,30,68,69],"Pancreatic Cancer","Glioma",[71,33,72],"Urokinase plasminogen activator receptor","Radiopharmaceutical","NOT_YET_RECRUITING","2026-06-08",{"date":76,"type":44},"2026-06-10",{"date":78,"type":22},"2026-06",{"date":80,"type":22},"2027-10",{"name":82,"class":51},"Hua Pang",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":63,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":52},"100643524","phase-4-comparing-intraoperative-indocyanine-green-fluorescence-imaging-with-standard-clinical-assessment-for-flap-perfusion-in-head-and-neck-reconstruction-vision-trial-100643524","NCT07635420","Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)","Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction: A Randomised Controlled Trial (VISION Trial)","VISION","Inclusion Criteria:\n\n* Age ≥18 years at the time of inclusion\n* Scheduled to undergo microvascular free flap reconstruction as part of oncologic, trauma, or benign surgery in the head and neck area\n* Ability to understand study information and provide written informed consent\n\nExclusion Criteria:\n\n* Known allergy to indocyanine green or iodine\n* Severe hepatic or renal impairment\n* Confirmed or suspected pregnancy\n* Breastfeeding",{"count":92,"type":22},244,[94],"PHASE4","This is a prospective multicentre randomised controlled trial evaluating whether intraoperative indocyanine green (ICG) fluorescence angiography improves outcomes in head and neck free flap reconstruction compared with standard clinical assessment of flap perfusion. Adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects will be randomised to either intraoperative ICG angiography or conventional clinical perfusion assessment. The primary outcome is partial flap loss requiring intervention within 30 days after surgery. Secondary outcomes include total flap loss, flap-related re-exploration, flap salvage, and postoperative complications.",[30,97,98,99,100,101,102,103],"Free Tissue Flaps","Free Flap","Free Flap Evaluation","Indocyanine Green","Indocyanine Green (ICG)","Microsurgery","Randomised Controlled Trial",{"date":105,"type":44},"2026-06-09",{"date":107,"type":22},"2026-10-01",{"date":109,"type":22},"2029-08-01",{"name":111,"class":51},"Region Skane",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100639254","ai-assisted-endoscopy-for-upper-aerodigestive-tract-lesions-100639254","NCT07596355","AI-Assisted Endoscopy for Upper Aerodigestive Tract Lesions","Head&Neck Application of Novel Computer-assisted Endoscopy","H&NANCE","Inclusion Criteria:\n\n* Age \\> 18 years\n* Injury originating from the upper aero-digestive tract\n* Recording of the video-endoscopic examination\n* Patient known to undergo a biopsy of the lesion or clinical follow-up for lesion with known biopsy (e.g. laryngeal papillomatosis) or suffering from Reinke's edema (in this pathology, in fact, biopsy is not necessary since the diagnosis is clinical)\n* Or patients undergoing transoral lesion excision\n\nExclusion Criteria:\n\n* Submucosal lesion\n* Patients with previous operations on the upper aero-digestive tract\n* Patients with previous radiotherapy of the head and neck district\n* Poor compliance on endoscopic examination\n* Unavailability of CADe\u002FCADx or CASe data logging note",{"count":121,"type":22},283,"This is a prospective observational clinical study designed to evaluate the performance of artificial intelligence (AI) algorithms applied to upper aerodigestive tract (UADT) video-endoscopy. The study assesses three main tasks: lesion detection (localization), classification (benign vs malignant), and segmentation of tumor margins.\n\nAI algorithms will be applied to endoscopic video data acquired during routine clinical practice without influencing clinical decision-making. The system will process images in real time and store data for subsequent analysis. AI outputs will be compared with physician assessment and reference standard histopathology to evaluate diagnostic performance.",[124,125,126,127,128,30,129,130,131],"Upper Aerodigestive Tract Neoplasms","Upper AerodigestiveTract Cancer","Upper Aero-digestive Tract (UADT) Neoplasm","Squamous Cell Carcinoma","Leukoplakia","Vocal Cord Disease","Vocal Fold Polyp","Vocal Fold Nodules","2026-05-12",{"date":134,"type":44},"2026-05-19",{"date":136,"type":22},"2026-05",{"date":138,"type":22},"2028-02",{"name":140,"class":51},"Istituto Italiano di Tecnologia",3,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":63,"phases":151,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":52},"100635854","evaluating-avive-soft-tissue-matrix-for-prevention-of-superficial-radial-nerve-morbidity-following-radial-forearm-free-flap-harvest-100635854","NCT07558096","Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest","A Randomized Controlled Pilot Study Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Undergoing RFFF for head and neck reconstruction\n* Treated at University of Alabama at Birmingham\n* Able to provide informed consent\n* Willing to comply with follow-up\n\nExclusion Criteria:\n\n* Reconstruction using a non-RFFF free flap\n* Pre-existing ipsilateral radial nerve neuropathy\n* Prior ipsilateral forearm surgery affecting nerve anatomy\n* Active donor-site infection\n* Severe peripheral vascular disease\n* Inability to complete follow-up",{"count":150,"type":22},80,[152],"NA","Radial forearm free flap (RFFF) reconstruction is commonly used for head and neck defects but is associated with donor-site morbidity, including neuropathic pain and sensory disturbance. This randomized controlled pilot study evaluates whether placement of a soft tissue matrix over the superficial radial nerve at the donor site reduces neuropathic pain and improves sensory outcomes compared to standard closure alone.",[30],[156,157,158,159,160,161],"Head and Neck Cancer","Radial forearm free flap","Neuropathic pain","Superficial radial nerve","Donor site morbidity","Soft tissue matrix","2026-05-04",{"date":164,"type":44},"2026-05-08",{"date":166,"type":22},"2026-07",{"date":168,"type":22},"2029-12",{"name":170,"class":51},"University of Alabama at Birmingham",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":63,"phases":179,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":200,"leadSponsor":202,"locationsCount":52},"100635482","effectiveness-of-09-normal-saline-soaking-in-managing-acute-radiation-dermatitis-100635482","NCT07553260","Effectiveness of 0.9% Normal Saline Soaking in Managing Acute Radiation Dermatitis","The Effectiveness of Saline Soaks in Managing Acute Radiation Dermatitis","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Patients receiving definitive radiotherapy for sarcomas or head and neck cancer (primary or postoperative treatment)\n* Planned radiation dose between 60-70 Gy according to disease-specific protocols\n* No prior history of malignancy other than sarcomas\n* Ability and willingness to comply with study procedures (\\>90% expected adherence)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients receiving palliative radiotherapy\n* Known pre-existing skin disorders affecting radiation area (e.g., systemic lupus erythematosus, scleroderma)\n* ECOG performance status ≥2\n* Previous radiotherapy to the same treatment field\n* Any condition that, in the investigator's judgment, may interfere with participation or wound healing assessment",{"count":21,"type":22},[152],"The goal of this clinical trial is to learn if normal saline soaks can reduce the severity of acute radiation dermatitis in patients with sarcomas or head and neck cancer receiving radiotherapy. It will also learn if saline soaks can improve wound healing and reduce treatment interruptions caused by skin toxicity. The main questions it aims to answer are:\n\n1. Does the application of normal saline soaks reduce the severity of acute radiation dermatitis according to CTCAE Version 5.0?\n2. Does the use of normal saline soaks improve wound healing time and reduce the frequency and duration of radiotherapy interruptions? Researchers will compare standard care plus saline soaks (intervention group) to standard care alone (control group) to see if saline soaks reduce skin reaction severity and improve clinical outcomes.\n\nParticipants will:\n\n1. Be randomly assigned to receive either standard care alone or standard care with daily saline soaks\n2. Apply saline-soaked gauze to the affected radiation area for 5-10 minutes once daily (intervention group only)\n3. Attend weekly clinic visits for skin assessment during radiotherapy\n4. Be assessed for skin reaction severity, wound healing, and treatment interruptions at baseline, after 4 weeks, and 2 weeks after completing treatment",[182,30,183],"Acute Radiation Dermatitis","Sarcomas",[185,186,187,188,189,190,191,192,193,194,195],"Dermatitis, Radiation-Induced","Skin Diseases, Radiation-Induced","Radiotherapy","Head and Neck Neoplasms","Sarcoma","Sodium Chloride","Wound Healing","Skin Care","Moist Desquamation","Supportive Care","Treatment Outcome","2026-04-20",{"date":198,"type":44},"2026-04-27",{"date":136,"type":22},{"date":201,"type":22},"2027-06",{"name":203,"class":51},"King Hussein Cancer Center",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":63,"phases":214,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":237},"100610295","access-to-care-pilot-for-ed-presenting-head-and-neck-cancer-patients-enrich-hnc-100610295","NCT07225725","Access to Care Pilot for ED-Presenting Head and Neck Cancer Patients (ENRICH-HNC)","Community Health Support for Emergency Department-Presenting Head and Neck Cancer Patients: A Pilot to Improve Access to Timely Care","ENRICH-HNC","Inclusion Criteria\n\n* Age 18 years or older\n* Presentation to the emergency department (ED) with a new or suspected head and neck cancer (including oral cavity, oropharynx, hypopharynx, larynx, salivary gland, cutaneous, sinonasal, nasopharyngeal, thyroid, or metastatic disease with unknown primary)\n* Residence within the regional catchment area of participating UTHSC-affiliated hospitals (Methodist University Hospital or Regional One Health)\n* Ability to provide informed consent electronically using REDCap eConsent after ED discharge\n* Has a valid telephone number for post-discharge contact\n\nExclusion Criteria\n\n* Prior or ongoing established head and neck oncology care at the time of ED presentation\n* Currently receiving hospice or palliative-only care\n* Incarcerated individuals\n* Inability to complete electronic informed consent (e.g., lack of decisional capacity or inability to complete consent even with staff assistance)\n* Lacks reliable telephone access or is unable to be reached after three documented contact attempts by study staff\n* Non-English or non-Spanish speaking when interpreter services are unavailable\n* Expected survival less than four weeks, as determined by the treating clinical team",{"count":213,"type":22},24,[152],"Patients diagnosed with head and neck cancer (HNC) after presenting to an emergency department (ED) often face significant delays in diagnosis and treatment. These patients are frequently younger, underinsured, and experience multiple socioeconomic and systems-level barriers to accessing timely cancer care. Delays of more than 30 days have been associated with worse outcomes, including higher recurrence rates and reduced survival.\n\nThis pilot study will evaluate the feasibility and early impact of a community-based navigation program designed to improve access to timely care for ED-presenting HNC patients. The study embeds trained Community Health Support Specialists (CHSS) from the Engaging Navigators to Reduce Inequities in Cancer Health (ENRICH) program into the ED-to-treatment pathway. After ED discharge, CHSS staff will contact participants by telephone or text message to identify barriers to care-such as transportation, insurance, housing, or communication challenges-and connect them with appropriate community or institutional resources.\n\nAll participants will receive the CHSS navigation intervention. Outcomes will be compared with a historical cohort of similar ED-presenting HNC patients treated prior to program implementation. The primary outcomes are time from ED discharge to diagnostic biopsy and time from ED discharge to initiation of definitive treatment. Secondary outcomes include feasibility, measured as the proportion of participants who complete CHSS navigation, and exploratory analyses of the types of barriers identified and resolved.\n\nFindings from this pilot will generate preliminary data to inform larger studies aimed at improving access, reducing disparities, and accelerating treatment for head and neck cancer patients who first present in the emergency setting.",[188,217,30],"Emergency Department Presentation",[219,220,221,222,223,224,225,226,227,156],"Emergency Department","Patient Navigation","Community Health Support","Health Equity","Cancer Care Access","Care Timeliness","Implementation Science","Engaging Navigators to Reduce Inequities in Cancer Health","ENRICH Program","2026-01-20",{"date":230,"type":44},"2026-01-22",{"date":232,"type":22},"2026-02-01",{"date":234,"type":22},"2027-01-31",{"name":236,"class":51},"University of Tennessee",2,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":63,"phases":247,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":270},"100493513","phase-1-a-study-to-assess-safety-tolerability-and-imaging-characteristics-of-68gaga-dpi-4452-and-to-assess-safety-tolerability-and-efficacy-of-177lulu-dpi-4452-in-participants-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100493513","NCT05706129","A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","A Multicenter, Open-Label, Non-Randomized Phase 1\u002F2 Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nPart A, B, and C:\n\n* Written informed consent, dated and signed by the patient prior to any study-specific procedure.\n* Part B and C are not conducted in the United States of America.\n* Has histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors of:\n* Clear cell renal cell cancer (ccRCC) - participants must have received at least one line containing Tyrosine kinase inhibitor (TKI) treatment and at least one line containing immune checkpoint inhibitor treatment in metastatic setting, meaning at least two lines of treatment in metastatic setting.\n* Pancreatic ductal adenocarcinoma (PDAC) - participants must have received at least one line of platinum- and\u002For gemcitabine-based regimen.\n* Colorectal cancer (CRC) - participants must have received at least one line of FOLFIRINOX or FOLFOX\u002FFOLFIRI in two lines in combination with anti-Vascular Endothelial Growth Factor (VEGF) or anti-Epidermal Growth Factor Receptor (EGFR).\n* Participants with CRC or PDAC: availability of fresh biopsy, OR an archival biopsy\u002Fsurgical specimen of the tumor (preferably, taken after last prior line of therapy).\n* For Part B and C only: Urothelial cancer (UC) patients must have received all available standard of care if eligible, including one line of platinum-based chemotherapy, enfortumab vedotin and pembrolizumab.\n* Presence of at least 1 non-irradiated tumor lesion detected at conventional imaging (computed tomography \u002F magnetic resonance imaging (CT\u002FMRI)) documented within 4 weeks prior to the \\[68Ga\\]Ga-DPI-4452 administration.\n* Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nPart D:\n\nParticipants with imaging evidence of a single indeterminate renal mass (IDRM) of ≤ 7 cm in largest diameter (tumor stage cT1) on any conventional diagnostic imaging technique, suspicious for ccRCC and planned for total or partial nephrectomy, or interventional diagnostic (cystoscopy and retrograde pyelography or biopsy) within 90 days from planned \\[68Ga\\]Ga-DPI-4452 administration.\n\nPart E:\n\nRegardless of lines of treatment, participants with histologically or cytologically confirmed progressive, unresectable locally advanced or metastatic solid tumors of\n\n* UC, including MIBC\n* H\\&N cancer\n* TNBC\n* Squamous NSCLC\n* Any other indication with confirmed carbonic anhydrase IX (CA IX) expression excluding ccRCC, PDAC and CRC, upon Sponsor agreement.\n\nPresence of at least 1 non-irradiated tumor lesion detected at conventional imaging (CT\u002FMRI) documented within 4 weeks prior to the \\[68Ga\\]Ga-DPI-4452 administration (for scans dated more than 4 weeks prior to D1, the Sponsor should be contacted to assess conventional imaging suitability)\n\nExclusion Criteria:\n\n* Any major surgery within 12 weeks before enrolment.\n* Inability to stay in the scanner bed with the arms resting out of the thoracic and abdominal fields (i.e., arms alongside the body or raised arm position) for the duration of the scan.\n\nPart A:\n\n* Has known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Bladder outflow obstruction or unmanageable urinary incontinence.\n* Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, and\u002For stable Grade 2 sensory neuropathy, according to National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\]).\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Previous Carbonic anhydrase (CA) IX-targeting treatment.\n* Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow, as judged by the Investigator.\n\nPart B and Part C:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Bladder outflow obstruction or unmanageable urinary incontinence.\n* Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, active clinically significant cardiac disease, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, or stable Grade 2 sensory neuropathy, according to NCI-CTCAE).\n* Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Any previous CA IX-targeting treatment for non-oncological indication within 3 months prior to the \\[177Lu\\]Lu-DPI-4452 infusion; any previous CA IX-targeting treatment for any oncological indication.\n* Participants who received any systemic antineoplastic therapy for the underlying disease and\u002For other investigational agents within a period which is ≤5 half-lives or ≤4 weeks (whichever is shorter).\n* Inflammatory bowel disease (e.g Crohn's disease, ulcerative colitis, etc).\n\nPart D:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Any previous CA IX-targeting treatment within 3 months prior to the \\[68Ga\\]Ga-DPI-4452 injection.\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.\n* Ongoing treatment with sulfonamides and\u002For coumarin derivatives (e.g., acenocoumarol, warfarin, phenprocoumon) within 2 weeks (or 5 half-lives, whichever is longer) prior to the \\[68Ga\\]Ga-DPI-4452 injection.\n\nPart E:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Any previous CA IX-targeting treatment within 3 months prior to \\[68Ga\\]Ga-DPI-4452 injection.\n* EBRT to more than 25% of the bone marrow, as judged by the Investigator.\n* Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.\n\nNote: Other inclusion\u002Fexclusion criteria mentioned in the protocol may apply.",{"count":246,"type":22},270,[248,249],"PHASE1","PHASE2","The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of \\[68Ga\\]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC); Part B: is to determine the recommended phase 2 dose (RP2D) \\[maximum tolerated dose (MTD) or lower dose\\] for \\[177Lu\\]Lu-DPI-4452 for each tumor type such as ccRCC, PDAC, CRC, and urothelial carcinoma (UC); Part C: is to evaluate the preliminary antitumor activity of \\[177Lu\\]Lu-DPI-4452 as monotherapy for each tumor type such as ccRCC, PDAC, CRC, and UC; Part D: is to assess the diagnostic concordance between \\[68Ga\\]Ga-DPI-4452 Positron Emission Tomography (PET) and the histopathology result of the Indeterminate Renal Mass (IDRM); Part E: is to assess \\[68Ga\\]Ga-DPI-4452 uptake in each tumour type such as UC, muscle invasive bladder cancer (MIBC), head and neck cancer (H\\&N), triple negative breast cancer (TNBC), squamous non-small cell lung cancer (NSCLC), and any other tumor with locally confirmed carbonic anhydrase (CA) IX expression except ccRCC, CRC and PDAC.",[252,253,254,255,256,257,30,258,259],"Clear Cell Renal Cell Cancer (ccRCC)","Pancreatic Ductal Adenocarcinoma (PDAC)","Colorectal Cancer (CRC)","Urothelial Carcinoma (UC)","Indeterminate Renal Mass (IDRM)","Muscle Invasive Bladder Cancer (MIBC)","Triple Negative Breast Cancer (TNBC)","Squamous Non-Small Cell Lung Cancer (NSCLC)","2025-10-16",{"date":262,"type":44},"2025-10-20",{"date":264,"type":44},"2023-03-14",{"date":266,"type":22},"2029-03",{"name":268,"class":269},"ITM Oncologics GmbH","INDUSTRY",10]