TheranosticTrials.org

Clinical Trial · NCT07609225

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

Overview

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.

Sponsor

University of Wisconsin, Madison

Phase

Early Phase 1

Contacts

Cancer Connect (CONTACT)

clinicaltrials@cancer.wisc.edu

800-622-8922

Michael Lawless, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07609225

Drug / Compound

FLT

Isotope(s):
Target(s):
  • cytosolic thymidine kinase 1
Ligand Class: Small Molecules

PSMA-617

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Individuals at least 18 years of age.
  • * Ability to understand and the willingness to sign a written informed consent document.
  • Patients must be clinically deemed appropriate for standard of care Lu-177 PSMA RPT.
  • Patients must have histologically or cytologically confirmed prostate cancer.
  • 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.

Exclusion

  • 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).
  • Patients treated with chemotherapy or 223Ra radiotherapy within 4 weeks.
  • * Patients receiving any concurrent therapy known to impact bone marrow (either stimulate or suppress the marrow, for example G-CSF).
  • 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.