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.

Study design
This is a single-site, single-arm study with a planned enrollment of 15 adult men.
What's involved
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.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 6 months after your last dose of 177Lu-PSMA RPT.

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NCT07609225

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

Not Yet Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
University of Wisconsin, Madison
~15 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:3'-Deoxy-3'-[18F]-fluorothymidineChemical-shift-encoded MRI

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Dice similarity coefficient (DSC)
Measured over up to 14 months
Metastatic Castration-resistant Prostate Cancer
1 sites across 1 states
Wisconsin1
  • Michael Lawless, PhD · PRINCIPAL_INVESTIGATOR · UW School of Medicine and Public Health

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Eligibility criteria

Inclusion

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

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.
  • Mean Dice similarity coefficient (DSC)up to 14 months

    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