[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07062549":3,"trial-entities:NCT07062549":109,"trial-summary:NCT07062549":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":52,"minimum_age":53,"maximum_age":17,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":78,"locations":81,"central_contacts":99,"overall_officials":104,"references":107,"see_also_links":108},"NCT07062549","J20116","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","RECRUITING","2029-07","2026-07","2026-07-21","2022-01-26","Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",true,"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",null,[19],"Renal Cell Carcinoma (Kidney Cancer)",[],"INTERVENTIONAL",[23],"PHASE1",{"count":25,"type":26},6,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"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",[33],"A (111In-XYIMSR-01)",[35],{"measure":36,"description":37,"timeFrame":38},"Number of adverse events","To evaluate the safety, tolerability, and feasibility of SPECT\u002FCT imaging with 111In-XYIMSR-01 measured by all adverse events according to CTCAE version 5.","From enrollment to the end of treatment at 1 week",[40,43,46,49],{"measure":41,"description":42,"timeFrame":38},"Biodistribution assessed by SPECT\u002FCT images","To determine the biodistribution and radiation dosimetry of 111In-XYIMSR-01",{"measure":44,"description":45,"timeFrame":38},"Radiation Dosimetry assessed by SPECT\u002FCT images","To determine radiation dosimetry of 111In-XYIMSR-01",{"measure":47,"description":48,"timeFrame":38},"Total Radioactivity Concentration of 111In-XYIMSR-01 in Plasma Over Time","To quantify the total radioactivity (expressed in counts per minute \\[CPM\\]) in plasma samples at specified time points following injection of 111In-XYIMSR-01",{"measure":50,"description":51,"timeFrame":38},"Number of lesions detected","Investigating the role of 111In-XYIMSR-01 SPECT\u002FCT as a diagnostic assessment tool in comparison to conventional imaging. To compare the number of lesions detected with 111In-XYIMSR-01 SPECT\u002FCT in comparison to conventional imaging all imaging modalities","ALL","18 Years",false,{"inclusion":56,"exclusion":71,"raw_text":77},[57,58,59,60,61,62,63,64,65,66,67,68,69,70],"Males or female sex","≥18 years of age","Willingness to provide signed informed consent and comply with all protocol requirements","Histological confirmation of RCC with a clear cell component","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","Screening clinical laboratory values as specified below:","Serum bilirubin ≤ 1.5 times the upper limit of normal; for patients with known Gilbert's syndrome, ≤ 3 × ULN is permitted","ALT ≤ 3 times the upper limits of normal","AST ≤ 3 times the upper limits of normal","Creatinine clearance ≥50 mL\u002Fmin based on Cockcroft-Gault formula","Absolute neutrophil count ≥ 1,500 \u002Fmm3","Platelets ≥100,000\u002F mm3","Hemoglobin ≥ 9.0 g\u002FdL","White blood cell count ≥ 2,000\u002F mm3",[72,73,74,75,76],"Systemic therapy for the treatment of ccRCC within 12 months of study enrollment.","Subjects administered any radioisotope within five physical half-lives prior to study drug injection.","Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.","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.","Women must not be breastfeeding.","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.",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":96},"Johns Hopkins University","Baltimore","Maryland","21287","United States",[89,94],{"name":90,"role":91,"phone":92,"email":93},"Yasser Ged, MBBS","CONTACT","410-955-8893","yged1@jhmi.edu",{"name":90,"role":95},"PRINCIPAL_INVESTIGATOR",{"lat":97,"lon":98},39.29038,-76.61219,[100,101],{"name":90,"role":91,"phone":92,"email":93},{"name":102,"role":91,"email":103},"Jasmine Brooks","jbrook54@jhmi.edu",[105],{"name":90,"affiliation":106,"role":95},"Johns Hopkins University SKCCC",[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Clear Cell Renal Cell Carcinoma",[],{"nct_id":4,"found":15,"summary":114,"prompt_version":124},{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an interventional study planning to enroll 6 participants. The study is testing 111In-XYIMSR-01.","completed","Study of 111In-XYIMSR-01 for Clear Cell Renal Cell Carcinoma","This study is looking at a new investigational radiotracer called 111In-XYIMSR-01. The goal is to see if this substance can help doctors better detect clear cell renal cell carcinoma (a type of kidney cancer) in your body when used with a SPECT-CT scan. You may be able to join if you are 18 or older, have clear cell renal cell carcinoma, and have 2-10 sites of disease that are at least 1.5 cm. The main way success will be measured is by tracking any side effects you might experience from the time you enroll until one week after treatment. The current recruitment status is unclear, and the study plans to enroll 6 participants.","Participants will be monitored for adverse events from enrollment to the end of treatment at 1 week.",113,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]