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

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07609225
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants scheduled to receive 177Lu-PSMA
    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.

Primary Outcome Measure

Mean Dice similarity coefficient (DSC) [ Time Frame: up to 14 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in Madison, WI

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Wisconsin Carbone Cancer Center· Madison, WI

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