RightFit
Not yet recruitingEarly Phase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 14 months, 6 months
  • Procedures mentioned: MRI scans, PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 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."
  • "This single-site, single-arm study will evaluate the accuracy of active bone marrow (ABM) segmentation with CSE-MRI by comparing to the established technique of FLT PET in patients with PSMA+ mCRPC who are scheduled to receive Lutetium-177 Prostate-Specific Membrane Antigen (177Lu-PSMA) (PLUVICTO®) Radiopharmaceutical Therapy (RPT) as standard of care."
  • "At the discretion of the prescribing physician, standard of care PSMA PET/MRI will be performed at any time during cycles 2-4, and also within 6 months of the final administration of 177Lu-PSMA RPT; during these scans, the CSE-MRI will also be acquired."
  • "Participants will be followed for 6 months following the final administration of 177Lu-PSMA RPT."
  • "The primary endpoint is a calculation of the mean Dice similarity coefficient (DSC) between active bone marrow volumes derived from CSE-MRI and ¹⁸F-FLT PET across all enrolled patients."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a special MRI scan works as well as an FLT PET scan to tell active bone marrow from inactive marrow. Bone marrow is the tissue inside bones that makes blood cells. The study is for adults with prostate cancer that has spread, and will enroll 15 people for up to 14 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Have prostate cancer confirmed by testing tissue or cells.
  • Be a good candidate for standard Lu-177 PSMA treatment, which uses radiation to target prostate cancer.
  • Be able to care for yourself and be up and about for at least half of your waking hours (ECOG score 0–2).
  • Understand that the study is experimental and has possible risks, and agree to sign a consent form.
  • Be able and willing to follow all study steps, including lying flat for at least 30 minutes during scans.

Who can't join

  • Currently getting another treatment that increases or slows bone marrow activity, such as G-CSF.
  • Had chemotherapy or radium-223 radiation treatment within the past 4 weeks.
  • Still have short-term side effects from past treatment that are more than moderate (above grade 2).
  • Have an illness that is not controlled, such as an active infection or certain heart problems, that your doctor says would limit your ability to follow study requirements.
  • Have a mental health condition or life situation that your doctor says would limit your ability to follow study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

WI