Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07609225 | Chemical-Shift-Encoded MRI for Active Bone Marrow Dosimetry in Radiopharmaceutical Therapy | EARLY_PHASE1 | NOT YET_RECRUITING | 15 | — | — | Jul 1, 2026 | Jul 1, 2029 | May 27, 2026 | 1 | United States |
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
| Arm | Type | Description |
|---|---|---|
| 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®). Within 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/MR scanner. Whole-body single photon emission computed tomography (SPECT/CT) imaging (2-3 bed positions) will be performed per standard of care on Day 0 (3 +/- 2 h), Day 1 (24 +/- 4 h), and Day 4 (96 +/- 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. |
| Name | Type | Description |
|---|---|---|
| 3'-Deoxy-3'-[18F]-fluorothymidine | DRUG | 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/MR scanner. This is expected to last 2-3 hours. FLT 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. The patient will receive 1 CSE-MRI/FLT PET scan prior to the start of therapy. |
| Chemical-shift-encoded MRI | DEVICE | 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/MR scanner. This is expected to last 2-3 hours. The patient will receive 1 CSE-MRI/FLT PET scan prior to the start of therapy. Up 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/MRI 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. |
Inclusion Criteria: * 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 understandin...