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Chemical-Shift-Encoded MRI for Active Bone Marrow Dosimetry in Radiopharmaceutical Therapy

StatusNot Yet Recruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Start date pushed from Sep 2026 to Oct 2026
    • Interventions: 3'-Deoxy-3'-[18F]-fluorothymidine (Drug), Chemical-shift-encoded MRI (Device) to 3'-Deoxy-3'-[18F]-fluorothymidine (Drug), Chemical-shift-encoded MRI (Device)
    • Eligibility criteria expanded, about 11 words
  2. Re-verified, no change to tracked fieldsv4
  3. Primary and study completion dates: Aug 2029 to Sep 2029
    • Start date: Aug 2026 to Sep 2026
    v3
  4. Primary and study completion pushed from Jul 2029 to Aug 2029
    • Start date: Jul 2026 to Aug 2026
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07609225
Lead Sponsor University of Wisconsin, Madison
Collaborators: GE Healthcare
Conditions
(from sponsor)		 Metastatic Castration-resistant Prostate Cancer
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov