[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07609225":3,"trial-entities:NCT07609225":109,"trial-summary:NCT07609225":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":47,"secondary_outcomes":52,"sex":65,"minimum_age":66,"maximum_age":14,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":83,"locations":86,"central_contacts":96,"overall_officials":102,"references":107,"see_also_links":108},"NCT07609225","2026-0693","Chemical-Shift-Encoded MRI for Active Bone Marrow Dosimetry in Radiopharmaceutical Therapy","NOT_YET_RECRUITING","2029-09","2026-08","2026-08-28","2026-09","University of Wisconsin, Madison","OTHER",null,"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.","This single-site, single-arm study will evaluate the accuracy of active bone marrow (ABM) segmentation with CSE-MRI by comparing to the established technique of FLT PET in patients with PSMA+ mCRPC who are scheduled to receive Lutetium-177 Prostate-Specific Membrane Antigen (177Lu-PSMA) (PLUVICTO®) Radiopharmaceutical Therapy (RPT) as standard of care. All standard of care testing, monitoring, and administration for 177Lu-PSMA RPT (PLUVICTO®) will be followed for this study.\n\nParticipants will receive 177Lu-PSMA RPT (PLUVICTO®) for a total of 6 doses, or until disease progression or unacceptable toxicity. Doses of 177Lu-PSMA RPT will be given at least 6 weeks apart. At the discretion of the prescribing physician, standard of care PSMA PET\u002FMRI will be performed at any time during cycles 2-4, and also within 6 months of the final administration of 177Lu-PSMA RPT; during these scans, the CSE-MRI will also be acquired. Participants will be followed for 6 months following the final administration of 177Lu-PSMA RPT.\n\nThe primary endpoint is a calculation of the mean Dice similarity coefficient (DSC) between active bone marrow volumes derived from CSE-MRI and ¹⁸F-FLT PET across all enrolled patients. A mean DSC of ≥0.7 will indicate that CSE-MRI is a clinically acceptable alternative to FLT PET for identifying ABM.\n\nWith the exception of the research-related CSE-MRI and FLT PET scans, all assessments, laboratory tests, RPT, and imaging scans are standard of care.",[18],"Metastatic Castration-resistant Prostate Cancer",[20,21,22,23],"FLT PET","CSE-MRI","active bone marrow","mCRPC","INTERVENTIONAL","TREATMENT",[27],"EARLY_PHASE1",{"count":29,"type":30},15,"ESTIMATED",[32,41],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"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.",[37],"Participants scheduled to receive 177Lu-PSMA",[39,40],"FLT","18F-FLT",{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"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.",[37],[21],[48],{"measure":49,"description":50,"timeFrame":51},"Mean Dice similarity coefficient (DSC)","The mean Dice similarity coefficient (DSC) between active bone marrow volumes derived from CSE-MRI and ¹⁸F-FLT PET across all enrolled patients. A mean DSC of ≥0.7 will indicate that CSE-MRI is a clinically acceptable alternative to FLT PET for identifying ABM","up to 14 months",[53,56,59,62],{"measure":54,"description":55,"timeFrame":51},"Difference in Mean Tumor Absorbed Dose (Gy)","Difference in mean tumor absorbed dose (Gy) across three lesion-segmentation methods, with segmentation performance characterized by DSC relative to physician manual contours.",{"measure":57,"description":58,"timeFrame":51},"Variance in Tumor and Bone Marrow Volume","Repeatability will be measured by variance in tumor and bone marrow volumes.",{"measure":60,"description":61,"timeFrame":51},"Variance in Tumor and Bone Marrow Doses","Repeatability will be measured by variance in tumor and bone marrow doses",{"measure":63,"description":64,"timeFrame":51},"Difference in Mean Absorbed Dose (Gy)","Difference in mean absorbed dose (Gy) between conventional and CSE-MRI-based ABM dosimetry methods","MALE","18 Years",false,{"inclusion":69,"exclusion":77,"raw_text":82},[70,71,72,73,74,75,76],"Ability to understand and the willingness to sign a written informed consent document.","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.","Individuals at least 18 years of age.","Patients must have histologically or cytologically confirmed prostate cancer.","Patients must be clinically deemed appropriate for standard of care Lu-177 PSMA RPT.","Eastern Cooperative Oncology Group (ECOG) performance 0-2","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.",[78,79,80,81],"Patients receiving any concurrent therapy known to impact bone marrow (either stimulate or suppress the marrow, for example G-CSF).","Patients treated with chemotherapy or 223Ra radiotherapy within 4 weeks.","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).","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.","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.",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"city":89,"state":90,"zip":91,"country":92,"geoPoint":93},"University of Wisconsin Carbone Cancer Center","Madison","Wisconsin","53792","United States",{"lat":94,"lon":95},43.07305,-89.40123,[97],{"name":98,"role":99,"phone":100,"email":101},"Cancer Connect","CONTACT","800-622-8922","clinicaltrials@cancer.wisc.edu",[103],{"name":104,"affiliation":105,"role":106},"Michael Lawless, PhD","UW School of Medicine and Public Health","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Prostate Carcinoma",[113],"FOLH1 Gene",{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is a single-site, single-arm study with a planned enrollment of 15 adult men.","completed","Imaging for Active Bone Marrow in Metastatic Prostate Cancer","This study is comparing two imaging methods, Chemical-shift-encoded MRI (CSE-MRI) and 18F-FLT PET, to see if CSE-MRI can accurately identify active bone marrow in men with metastatic castration-resistant prostate cancer. Participants will receive 177Lu-PSMA RPT (PLUVICTO®) as part of their standard care. Before starting treatment, you'll have both an 18F-FLT PET scan and a CSE-MRI scan. The goal is to determine if CSE-MRI is as good as 18F-FLT PET at finding active bone marrow. The study aims for at least 15 participants and is currently unclear on its recruitment status.","You will be followed for 6 months after your last dose of 177Lu-PSMA RPT.",90,"You will undergo an 18F-FLT PET scan and a CSE-MRI scan, expected to last 2-3 hours, within 29 days before starting 177Lu-PSMA RPT. You will also receive 177Lu-PSMA RPT (PLUVICTO®) for up to 6 doses, given at least 6 weeks apart.","Not stated in the trial record.",[43],"v2"]