[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06986304":3,"trial-entities:NCT06986304":74,"trial-summary:NCT06986304":78},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":16,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":26,"secondary_outcomes":31,"sex":32,"minimum_age":33,"maximum_age":16,"healthy_volunteers":34,"eligibility_criteria":35,"std_ages":46,"locations":49,"central_contacts":66,"overall_officials":70,"references":72,"see_also_links":73},"NCT06986304","Pro00117744","Characterizing the Microvascular Environment of Bladder Cancer With Super-Resolution Ultrasound Localization Microscopy","RECRUITING","2027-04","2026-04","2026-05-04","2025-10-28","Duke University","OTHER",true,"The project will include 30 patients with bladder cancer who are candidates for bladder removal. After signing the consent form, the study team will collect some clinical data, such as age, past medical history, past surgical history, and information about your current disease.\n\nAt the day of surgery, after putting participants into sleep and before surgery begins, the study team will do a novel ultrasound called \"Super-Resolution Ultrasound Localization Microscopy\" to check if there is still disease in the bladder. The team will then compare the results of this investigational ultrasound with the final pathology and other imaging studies.",null,[18],"Bladder Cancer",[],"OBSERVATIONAL",[],{"count":23,"type":24},30,"ESTIMATED",[],[27],{"measure":28,"description":29,"timeFrame":30},"Presence and stage of residual bladder cancer at the time of RC.","The primary outcome variable is the presence and stage of residual bladder cancer at the time of RC. Statistical tests such as logistic regression will be applied to assess the accuracy of quantitative SR-ULM biomarkers in detecting residual bladder cancer.","From enrollment to first post-cystectomy follow-up visit (1 month)",[],"ALL","18 Years",false,{"inclusion":36,"exclusion":39,"raw_text":45},[37,38],"Adults \\> 18 years","Histological evidence of urothelial cancer of the bladder for which radical cystectomy is recommended as per the treating physician (e.g., MIBC or high-risk NMIBC, such as high-grade T1 BCG refractory and worrisome histological variants)",[40,41,42,43,44],"Known or suspected hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG).","Pregnancy or breastfeeding","Decline to participate in the study","Participants who had serious allergic reactions to COVID-19 vaccination.","Participants with unstable conditions such as hospital in-patients, ICU patients, or high-risk cardiac diseases.","Inclusion Criteria:\n\n* Adults \\> 18 years\n* Histological evidence of urothelial cancer of the bladder for which radical cystectomy is recommended as per the treating physician (e.g., MIBC or high-risk NMIBC, such as high-grade T1 BCG refractory and worrisome histological variants)\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG).\n* Pregnancy or breastfeeding\n* Decline to participate in the study\n* Participants who had serious allergic reactions to COVID-19 vaccination.\n* Participants with unstable conditions such as hospital in-patients, ICU patients, or high-risk cardiac diseases.",[47,48],"ADULT","OLDER_ADULT",[50],{"facility":12,"status":7,"city":51,"state":52,"zip":53,"country":54,"contacts":55,"geoPoint":63},"Durham","North Carolina","27710","United States",[56,60],{"name":57,"role":58,"phone":59},"Alireza Ghoreifinejadian, M.D.","CONTACT","919-684-8111",{"name":61,"role":62},"Michael Abern, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":64,"lon":65},35.99403,-78.89862,[67],{"name":61,"role":58,"phone":68,"email":69},"919-684-5057","michael.abern@duke.edu",[71],{"name":61,"affiliation":12,"role":62},[],[],{"nct_id":4,"conditions":75,"biomarkers":77},[76],"Bladder Carcinoma",[],{"nct_id":4,"found":14,"summary":79,"prompt_version":89},{"design":80,"status":81,"heading":82,"summary":83,"follow_up":84,"word_count":85,"commitments":86,"compensation":87,"drugs_mentioned":88},"This is an observational study involving 30 participants. It is not testing a new treatment, but rather a new way to image bladder cancer.","completed","Observational Study of Super-Resolution Ultrasound for Bladder Cancer","This study is looking at a new type of ultrasound called \"Super-Resolution Ultrasound Localization Microscopy\" to see how well it can find bladder cancer. It includes 30 patients who have bladder cancer and are planning to have their bladder removed. Before your surgery, while you are asleep, the study team will use this special ultrasound to check for cancer in your bladder. The results from this ultrasound will then be compared with the findings from your surgery and other imaging tests. This helps researchers understand if this new ultrasound can accurately detect cancer that is still present.","Your condition will be assessed from enrollment until your first follow-up visit about one month after your bladder removal surgery.",97,"If you join, the study team will collect your medical history. On the day of your surgery, before the operation begins, you will have a Super-Resolution Ultrasound Localization Microscopy scan while you are asleep.","Not stated in the trial record.",[],"v2"]