Clinical trial · Interventional
Chemical-Shift-Encoded MRI for Active Bone Marrow Dosimetry in Radiopharmaceutical Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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/MR 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3'-Deoxy-3'-[18F]-fluorothymidine | Drug | — | UNRESOLVED |
| Chemical-shift-encoded MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants scheduled to receive 177Lu-PSMA
- description
- 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.
- interventionNames
- Drug: 3'-Deoxy-3'-[18F]-fluorothymidine
- Device: Chemical-shift-encoded MRI
Primary outcomes (1)
- measure
- Mean Dice similarity coefficient (DSC)
- timeFrame
- up to 14 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 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. Exclusion Criteria: * 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/social situations that would limit compliance with study requirements per treating physician discretion.
References
Publications (0)
Data not yet available