[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638106":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":31,"centralContacts":36,"locations":43,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":41,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":41,"enrollmentInfo":71,"targetDuration":41,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":84,"whyStopped":41,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Wisconsin, Madison","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants scheduled to receive 177Lu-PSMA","EXPERIMENTAL","Males aged 18 years and older with metastatic PSMA-positive castration-resistant prostate cancer (CRPC) who are scheduled to receive 177Lu-PSMA (PLUVICTO®).\n\nWithin 7 days prior to 177Lu-PSMA RPT, participants will receive an injection of FLT and then undergo a FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET\u002FMR scanner. Whole-body single photon emission computed tomography (SPECT\u002FCT) imaging (2-3 bed positions) will be performed per standard of care on Day 0 (3 +\u002F- 2 h), Day 1 (24 +\u002F- 4 h), and Day 4 (96 +\u002F- 24 h) post-177Lu-PSMA RPT infusion. As standard of care, participants will receive up to 6 infusions of 177Lu-PSMA RPT every 6 weeks at UW Health.",[13,14],"Drug: 3'-Deoxy-3'-[18F]-fluorothymidine","Device: Chemical-shift-encoded MRI",[16,24],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","3'-Deoxy-3'-[18F]-fluorothymidine","Within 29 days prior to 177Lu-PSMA RPT, participants will undergo 18F-FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET\u002FMR scanner. This is expected to last 2-3 hours.\n\nFLT injections will be administered one hour before imaging for tracer uptake. Participants will receive an IV injection of up to 10 mCi (370 MBq) of 18F-FLT.\n\nThe patient will receive 1 CSE-MRI\u002FFLT PET scan prior to the start of therapy.",[9],[22,23],"FLT","18F-FLT",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Chemical-shift-encoded MRI","Within 29 days prior to 177Lu-PSMA RPT, participants will undergo 18F-FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET\u002FMR scanner. This is expected to last 2-3 hours. The patient will receive 1 CSE-MRI\u002FFLT PET scan prior to the start of therapy.\n\nUp to 3 CSE-MRI scans will be completed as part of this study. At the physician's discretion, a single standard of care (SOC) mid-treatment PSMA PET\u002FMRI can be performed any time during cycles 2-4, and a SOC post-treatment can be done within 6 months of final treatment. CSE-MRI will be acquired during these scans.",[9],[30],"CSE-MRI",[32],{"name":33,"affiliation":34,"role":35},"Michael Lawless, PhD","UW School of Medicine and Public Health","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Cancer Connect","CONTACT","800-622-8922",null,"clinicaltrials@cancer.wisc.edu",[44],{"facility":45,"status":41,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":41},"University of Wisconsin Carbone Cancer Center","Madison","Wisconsin","53792","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-89.40123,43.07305,{"lat":55,"lon":54},{"type":58,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[60],{"name":61,"class":62},"GE Healthcare","INDUSTRY","100638106","early-phase-1-chemical-shift-encoded-mri-for-active-bone-marrow-dosimetry-in-radiopharmaceutical-therapy-100638106",false,"NCT07609225","Chemical-Shift-Encoded MRI for Active Bone Marrow Dosimetry in Radiopharmaceutical Therapy","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document.\n* Patients must be informed of the experimental nature of the study and its potential risks, and must sign institutional review board (IRB) approved consent form indicating such understanding.\n* Individuals at least 18 years of age.\n* Patients must have histologically or cytologically confirmed prostate cancer.\n* Patients must be clinically deemed appropriate for standard of care Lu-177 PSMA RPT.\n* Eastern Cooperative Oncology Group (ECOG) performance 0-2\n* Patients must be able to comply with all study procedures, including having both the ability and willingness to lie flat for ≥ 30 minutes during imaging.\n\nExclusion Criteria:\n\n* Patients receiving any concurrent therapy known to impact bone marrow (either stimulate or suppress the marrow, for example G-CSF).\n* Patients treated with chemotherapy or 223Ra radiotherapy within 4 weeks.\n* All acute toxic effects of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to a grade ≤ 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (CTCAE).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements per treating physician discretion.","MALE","18 Years",{"count":72,"type":73},15,"ESTIMATED","INTERVENTIONAL",[76],"EARLY_PHASE1","This study compares two different imaging procedures to each other, one using positron emission tomography (PET) with fluorothymidine F-18 (FLT) (FLT PET for short), and the other using chemical shift-encoded (CSE) magnetic resonance imaging (MRI) or CSE-MRI for short, to determine specifically if CSE-MRI is as accurate as FLT PET in telling the difference between active and inactive marrow. The best way to do the comparison between the two imaging procedures is if they are done at the same time on the same patient. This is possible with use of a scanner at the University of Wisconsin Hospitals and Clinics (UW Health), the GE SIGNA PET\u002FMR scanner. The prediction is that CSE-MRI as accurate as FLT at telling the difference between active and inactive marrow in patients with metastatic prostate cancer, and that is the primary reason for this study. 15 participants will be enrolled and on study for up to 14 months.",[79],"Metastatic Castration-resistant Prostate Cancer",[81,30,82,83],"FLT PET","active bone marrow","mCRPC","NOT_YET_RECRUITING","2026-07-22",{"date":87,"type":88},"2026-07-23","ACTUAL",{"date":90,"type":73},"2026-08",{"date":92,"type":73},"2029-08",{"name":5,"class":6},1]