[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597750":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":52,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":20,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":20,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"A (111In-XYIMSR-01)","EXPERIMENTAL","Participants who receive 111In-XYIMSR-01 dosing and SPECT\u002FCT imaging",[13],"Drug: 111In-XYIMSR-01",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","111In-XYIMSR-01","Unite Dose: 10.5±1 mCi of 111In-XYIMSR-01 Route of administration: Intravenous catheter placed in an antecubital vein or an equivalent venous access",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Yasser Ged, MBBS","Johns Hopkins University SKCCC","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","410-955-8893","yged1@jhmi.edu",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},"Jasmine Brooks","jbrook54@jhmi.edu",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Johns Hopkins University","RECRUITING","Baltimore","Maryland","21287","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-76.61219,39.29038,{"lat":47,"lon":46},[50,51],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100597750","phase-1-study-of-111in-xyimsr-01-spectct-in-patients-with-metastatic-clear-cell-renal-cell-100597750",false,"NCT07062549","Study of 111In-XYIMSR-01 SPECT\u002FCT in Patients With Metastatic Clear Cell Renal Cell","First-in-Human Study of 111In-XYIMSR-01 SPECT\u002FCT in Patients With Metastatic Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n* Males or female sex\n* ≥18 years of age\n* Willingness to provide signed informed consent and comply with all protocol requirements\n* Histological confirmation of RCC with a clear cell component\n* 2-10 sites of disease measuring ≥1.5 cm on contrast-enhanced CT and\u002For MRI imaging of the chest, abdomen and pelvis performed ≤60 days prior to the date of study enrollment\n* Screening clinical laboratory values as specified below:\n\n  * Serum bilirubin ≤ 1.5 times the upper limit of normal; for patients with known Gilbert's syndrome, ≤ 3 × ULN is permitted\n  * ALT ≤ 3 times the upper limits of normal\n  * AST ≤ 3 times the upper limits of normal\n  * Creatinine clearance ≥50 mL\u002Fmin based on Cockcroft-Gault formula\n  * Absolute neutrophil count ≥ 1,500 \u002Fmm3\n  * Platelets ≥100,000\u002F mm3\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * White blood cell count ≥ 2,000\u002F mm3\n\nExclusion Criteria:\n\n* Systemic therapy for the treatment of ccRCC within 12 months of study enrollment.\n* Subjects administered any radioisotope within five physical half-lives prior to study drug injection.\n* Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.\n* Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin) within 24 hours prior to the imaging day.\n* Women must not be breastfeeding.","ALL","18 Years",{"count":64,"type":65},6,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","This study is being done to determine if the investigational radiotracer called 111In-XYIMSR-01 is helpful in detecting clear cell renal cell carcinoma tissue in your body when used during a SPECT-CT Scan",[71],"Renal Cell Carcinoma (Kidney Cancer)","2025-07-17",{"date":74,"type":75},"2025-07-23","ACTUAL",{"date":77,"type":75},"2022-01-26",{"date":79,"type":65},"2029-07",{"name":5,"class":6},1]