[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03653702":3,"trial-entities:NCT03653702":88,"trial-summary:NCT03653702":92},{"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":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":52,"locations":55,"central_contacts":74,"overall_officials":82,"references":86,"see_also_links":87},"NCT03653702","P00027566","Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)","NOT_YET_RECRUITING","2029-07","2025-12","2026-07-22","2027-07-01","Boston Children's Hospital","OTHER",true,"In this research study the investigators want to study a safe, radiation-free technique known as contrast-enhanced ultrasound that may improve the ability to diagnose or evaluate renal scarring compared to regular ultrasound. This technique requires injection into a vein of a small amount of contrast material called Lumason. Contrast material is a type of dye that helps the investigators image the structures in the body more clearly. If this technique is successful, the need for DMSA studies may be avoided to diagnose or evaluate kidney scarring. DMSA is a more expensive test, causes radiation exposure, may require sedation and\u002For injection of contrast agents with the potential to cause allergic reactions.",null,[18],"Vesico-Ureteral Reflux",[],"INTERVENTIONAL","DIAGNOSTIC",[23],"PHASE1",{"count":25,"type":26},70,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"DRUG","Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]","Lumason will be used as the contrast agent. Standard Lumason dose will be used: 0.03mL\u002Fkg up to a maximum dose of 2.4 milliliter (mL) per injection",[33],"Contrast Enhanced Ultrasound",[35],"Lumason",[37],{"measure":38,"description":39,"timeFrame":40},"Performance of CEUS result and comparison to DMSA","DMSA will be used as gold standard to evaluate CEUS test performance. Sensitivity and specificity of CEUS renal scarring detection will be calculated accordingly. Bivariate and multivariate analyses will be completed to compare patient characteristics between those with good and poor CEUS performance to investigate if CEUS performs better in patients with specific covariates","3 months after final participant completes participation",[],"ALL","6 Months","35 Years",false,{"inclusion":47,"exclusion":49,"raw_text":51},[48],"patients older than or equal to 6 months and less than or equal to 35 years old and scheduled for Boston Children's Hospital (BCH) DMSA scan to evaluate renal function and\u002For renal scarring",[50],"patients with significant congenital renal anatomical abnormalities including horseshoe kidney, kidney malrotation, and multicystic dysplastic kidney (MCDK). Patients with severe cardio-pulmonary diseases will also be excluded.","Inclusion Criteria:\n\n* patients older than or equal to 6 months and less than or equal to 35 years old and scheduled for Boston Children's Hospital (BCH) DMSA scan to evaluate renal function and\u002For renal scarring\n\nExclusion Criteria:\n\n* patients with significant congenital renal anatomical abnormalities including horseshoe kidney, kidney malrotation, and multicystic dysplastic kidney (MCDK). Patients with severe cardio-pulmonary diseases will also be excluded.",[53,54],"CHILD","ADULT",[56],{"facility":12,"city":57,"state":58,"zip":59,"country":60,"contacts":61,"geoPoint":71},"Boston","Massachusetts","02115","United States",[62,67],{"name":63,"role":64,"phone":65,"email":66},"Amy Chan, B.A.","CONTACT","347-854-6840","amy.chan@childrens.harvard.edu",{"name":68,"role":64,"phone":69,"email":70},"Emily Morrison, B.S.","617-919-2637","emily.morrison@childrens.harvard.edu",{"lat":72,"lon":73},42.35843,-71.05977,[75,79],{"name":76,"role":64,"phone":77,"email":78},"Vera Rodic, MPH","8572621693","vera.rodic@childrens.harvard.edu",{"name":80,"role":64,"email":81},"Katherine Regis","Katherine.Regis@childrens.harvard.edu",[83],{"name":84,"affiliation":12,"role":85},"Richard Lee","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":89,"biomarkers":91},[90],"Vesicoureteral Reflux",[],{"nct_id":4,"found":14,"summary":93,"prompt_version":102},{"design":94,"status":95,"heading":6,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is an interventional study planning to enroll 70 participants. It is not specified if it is randomized or blinded.","completed","This study is testing a radiation-free technique called contrast-enhanced ultrasound to evaluate kidney scarring, which is often caused by vesico-ureteral reflux (VUR). This technique uses a contrast agent called Lumason (Sulfur Hexafluoride Lipid Type A Microspheres) injected into a vein to help doctors see kidney structures more clearly. The goal is to see if this method can replace DMSA scans, which involve radiation exposure. You might be able to join if you are between 6 months and 35 years old, have VUR, and are scheduled for a DMSA scan at Boston Children's Hospital. The study will be considered successful if the contrast-enhanced ultrasound results compare well to DMSA scans. The current status of this study is unclear.","The primary endpoint will be measured at 3 months after the final participant completes participation.",117,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]