[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396486":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":76,"collaborators":79,"id":83,"slug":21,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":21,"enrollmentInfo":91,"targetDuration":21,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":104,"overallStatus":40,"whyStopped":21,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Cedars-Sinai Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm - Bladder Chemo-Radiotherapy","EXPERIMENTAL","Fiducial marker placement \\& cystogram during resection surgery, followed by radiation planning CT scan, mpMRI, chemo-radiation treatment; mpMRI and\u002For surveillance cystoscopy at 3, 6, and 9 months post-treatment.",[13,14],"Procedure: Fiducial marker placement","Diagnostic Test: Multiparametric MRI (mpMRI)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"PROCEDURE","Fiducial marker placement","placement of 24k gold fiducial markers surrounding the tumor site, at time of primary or re-staging bladder tumor resection",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DIAGNOSTIC_TEST","Multiparametric MRI (mpMRI)","In this study, mp-MRI is defined as MRI that includes T1 \\& T2 weighted sequences, diffusion weighted sequences, and Dynamic contrast enhanced (DCE) MRI sequences.",[9],[28],{"name":29,"affiliation":5,"role":30},"Maurice Garcia, MD","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Laura Sarmiento, CCRP","CONTACT","310-423-4295","laura.sarmiento@cshs.org",[38,51,62],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":21},"Cedars-Sinai Medical Center (CSMC)","RECRUITING","Los Angeles","California","90048","United States",{"type":46,"coordinates":47},"Point",[48,49],-118.24368,34.05223,{"lat":49,"lon":48},{"facility":52,"status":40,"city":41,"state":42,"zip":53,"country":44,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"University of California Los Angeles","90095",{"type":46,"coordinates":55},[48,49],{"lat":49,"lon":48},[58],{"name":59,"role":34,"phone":60,"phoneExt":21,"email":61},"Jackie Hernandez, CCRP","310-267-8991","jhernandez@mednet.ucla.edu",{"facility":63,"status":40,"city":64,"state":65,"zip":66,"country":44,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Harvard School of Medicine\u002FMassachusetts General Hospital (MGH)","Boston","Massachusetts","02114",{"type":46,"coordinates":68},[69,70],-71.05977,42.35843,{"lat":70,"lon":69},[73],{"name":74,"role":34,"phone":21,"phoneExt":21,"email":75},"Sarah Stec","SSTEC@mgh.harvard.edu",{"type":30,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Maurice M. Garcia","Principal Investigator",[80],{"name":81,"class":82},"National Cancer Institute (NCI)","NIH","100396486",false,"NCT04442724","Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy","FMBRT","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. Subjects with mixed histology are required to have a dominant traditional cell carcinoma (TCC) pattern.\n* Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder\n* Planned TURBT as part of the normal course treatment, to take place prior to the initiation of chemo irradiation\n* Adequate renal function: Serum creatinine \\\u003C 2 mg\u002FdL OR calculated creatinine clearance (CrCl) \\> 30ml\u002Fmin\n* Ability to understand and willingness to sign a written informed consent\n* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during study participation, and for 90 days after study treatment discontinuation\n\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n\nExclusion Criteria:\n\n* Subjects with primary TCC of the ureter, urethra, or renal pelvis, without TCC of the bladder, are not allowed\n* Known distant metastatic disease (e.g. pulmonary or hepatic metastases)\n\n  * Subjects with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of complete resection of all malignant disease are allowed\n* Patients with bladder abnormalities that preclude safe placement of fiducial markers (i.e. abundant large diverticuli or cellules, active or recurrent urinary infection)\n* Planned (or prior history of) definitive bladder irradiation\n* Intravesical chemo- or biologic therapy within 6 weeks of first treatment\n* Any planned neoadjuvant systemic immunotherapy. Note that prior bacille Calmette-Guerin vaccine (BCG) is not an exclusion\n* Clinically significant active infection or uncontrolled medical condition that would preclude participation in study\n* Pregnant or nursing women are excluded\n* Previous malignancy other than TCC that, in the opinion of the treating investigator, is likely to interfere with protocol treatment\n* Individuals with severe renal failure and cannot receive MRI contrast","ALL","18 Years",{"count":92,"type":93},60,"ESTIMATED","INTERVENTIONAL",[96],"NA","The purpose of this study is to examine the usefulness of implanting small 24-K gold fiducial markers around a bladder tumor site, so that a Radiation Oncologist can identify the original tumor location at the time of radiation treatment. Other goals of the study include assessing whether a new MRI imaging technology can help with detection of bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope.",[99,100,101,102,103],"Bladder Cancer","Urinary Bladder Neoplasm","Urologic Neoplasms","Neoplasms","Urinary Bladder Diseases",[105,106],"Fiducial marker","Fiducial marker guided technique","2025-08-11",{"date":109,"type":110},"2025-08-14","ACTUAL",{"date":112,"type":110},"2020-07-01",{"date":114,"type":93},"2026-06-30",{"name":5,"class":6},3]