[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06116253":3,"trial-entities:NCT06116253":86,"trial-summary:NCT06116253":90},{"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":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":42,"secondary_outcomes":47,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":67,"locations":70,"central_contacts":78,"overall_officials":79,"references":84,"see_also_links":85},"NCT06116253","21-01230","Advanced Diffusion Imaging in Renal Cancer Patients","Advanced Diffusion Imaging in Renal Cancer Patients: Oncologic Control and Renal Functional Reserve","ACTIVE_NOT_RECRUITING","2028-12-01","2026-04","2026-05-08","2022-12-01","NYU Langone Health","OTHER",true,"The objective of this study is to apply advanced diffusion imaging in a two-pronged assessment of renal mass patients: (1) characterization of lesion malignancy and subtype, and (2) prediction of renal function stability or decline following partial nephrectomy.",null,[19],"Renal Cancer",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"NA",{"count":26,"type":27},39,"ACTUAL",[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DEVICE","Magnetic Resonance Imaging (MRI) Scan","Participants will undergo a 1-hour research MRI scan.",[34],"Renal Mass Patients",[36],"Prisma 3T scanner",{"type":38,"name":39,"description":40,"armGroupLabels":41},"DRUG","Tc-99m Pentetate","Participants will receive radioisotope (99mTc-DTPA) injection (5 mCi) during 3-5 hour scanning session to estimate measured glomerular filtration rate (mGFR).",[34],[43],{"measure":44,"description":45,"timeFrame":46},"Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery","Intravoxel incoherent imaging-MRI (IVIM-MRI) data will be used to predict lesion type.","Baseline (1 Week Prior to Operation)",[48],{"measure":49,"description":50,"timeFrame":51},"Percentage of Times Post-Surgical Renal Function is Correctly Predicted Using REFMAP-MRI at Pre-Surgery","Results from the Renal Flow and Microstructure AnisotroPy-MRI (REFMAP-MRI) pre-surgical scan will be considered as predictors for either stability in renal function or incremental decline in renal function following surgery that would lead to chronic kidney disease (CKD), as defined by mGFR values and proteinuria status at follow-up.\n\nPost-surgical renal insult will be assessed based on either mGFR decline by over 2 ml\u002Fmin\u002F1.73 m2 per year or the appearance of proteinuria.","Up to Year 1 Post-Operation","ALL","21 Years","85 Years",false,{"inclusion":57,"exclusion":62,"raw_text":66},[58,59,60,61],"Renal mass patients scheduled for laparoscopic partial nephrectomy.","eGFR above 30 ml\u002Fmin\u002Fm2.","Ages 21 to 85","Must be willing and able to provide consent.",[63,64,65],"All metal implants and dental implants that have ferromagnetic properties and are unsafe at 3.0 T.","Pregnant women are not eligible for participating in this study.","Acute claustrophobia","Inclusion Criteria:\n\n* Renal mass patients scheduled for laparoscopic partial nephrectomy.\n* eGFR above 30 ml\u002Fmin\u002Fm2.\n* Ages 21 to 85\n* Must be willing and able to provide consent.\n\nExclusion Criteria:\n\n* All metal implants and dental implants that have ferromagnetic properties and are unsafe at 3.0 T.\n* Pregnant women are not eligible for participating in this study.\n* Acute claustrophobia",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":13,"city":72,"state":72,"zip":73,"country":74,"geoPoint":75},"New York","10016","United States",{"lat":76,"lon":77},40.71427,-74.00597,[],[80],{"name":81,"affiliation":82,"role":83},"Eric Sigmund, PhD","NYU Langone Medical Center","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":87,"biomarkers":89},[88],"Kidney Carcinoma",[],{"nct_id":4,"found":15,"summary":91,"prompt_version":101},{"design":92,"status":93,"heading":94,"summary":95,"follow_up":96,"word_count":97,"commitments":98,"compensation":99,"drugs_mentioned":100},"This study plans to enroll 39 participants. It is an interventional study, meaning participants will receive specific interventions.","completed","Advanced Imaging for Renal Cancer Patients","This study is looking at new ways to use advanced imaging to better understand kidney (renal) cancer. Researchers are using a special type of MRI scan called advanced diffusion imaging, along with an injection of Tc-99m Pentetate (a radioactive tracer) to measure kidney function. The goal is to see if these methods can accurately identify the type of kidney tumor and predict how well your kidneys will work after surgery. They are looking for 39 participants aged 21 to 85 who have a kidney mass and are scheduled for a specific type of surgery called a laparoscopic partial nephrectomy. The main goal is to see how accurately the imaging can predict the tumor type before surgery.","The primary outcome is measured at baseline, which is one week prior to your operation.",116,"You would undergo a 1-hour research MRI scan and receive an injection of Tc-99m Pentetate during a 3-5 hour scanning session. This happens about one week before your surgery.","Not stated in the trial record.",[39],"v2"]